FDA Drugs July 2013.  Previous Month Next

New Post Public Reply Private Reply Replies (0) Message Board
PoemStone

FDA Drugs July 2013.

< Previous Month Next Month >


Drug Name

and
FDA Appl. #

Suppl. #

Active
Ingredients

Company

Approval
Type

Approval
Date
ORTHO EVRA
(NDA # 021180)

044 ETHINYL ESTRADIOL; NORELGESTROMIN JANSSEN PHARMS Labeling Revision 07/01/2013
TRACLEER
(NDA # 021290)

025 BOSENTAN ACTELION PHARMS LTD Labeling Revision 07/01/2013
RIZATRIPTAN BENZOATE
(ANDA # 078739)

000 RIZATRIPTAN BENZOATE SANDOZ Approval 07/01/2013
FINASTERIDE
(ANDA # 090060)

000 FINASTERIDE HETERO LABS LTD III Approval 07/01/2013
FINASTERIDE
(ANDA # 090508)

000 FINASTERIDE SUN PHARMA GLOBAL Approval 07/01/2013
RASAGILINE MESYLATE
(ANDA # 201823)

000 RASAGILINE MESYLATE WATSON LABS INC Approval 07/01/2013
RIZATRIPTAN BENZOATE
(ANDA # 201914)

000 RIZATRIPTAN BENZOATE GLENMARK GENERICS Approval 07/01/2013
ARIPIPRAZOLE
(ANDA # 202102)

000 ARIPIPRAZOLE ALEMBIC PHARMS LTD Tentative Approval 07/01/2013
RIZATRIPTAN BENZOATE
(ANDA # 202477)

000 RIZATRIPTAN BENZOATE APOTEX INC Approval 07/01/2013
GATIFLOXACIN
(ANDA # 202653)

000 GATIFLOXACIN LUPIN LTD Tentative Approval 07/01/2013
RILUZOLE
(ANDA # 203042)

000 RILUZOLE MYLAN PHARMS INC Approval 07/01/2013
RIZATRIPTAN BENZOATE
(ANDA # 203062)

000 RIZATRIPTAN BENZOATE AUROBINDO PHARMA LTD Approval 07/01/2013
RIZATRIPTAN BENZOATE
(ANDA # 203478)

000 RIZATRIPTAN BENZOATE NATCO PHARMA LTD Approval 07/01/2013
RIZATRIPTAN BENZOATE
(ANDA # 204339)

000 RIZATRIPTAN BENZOATE INVAGEN PHARMS Approval 07/01/2013
EFUDEX
(NDA # 016831)

056 FLUOROURACIL VALEANT PHARM INTL Manufacturing Change or Addition 07/02/2013
NASACORT AQ
(NDA # 020468)

033 TRIAMCINOLONE ACETONIDE SANOFI AVENTIS US Efficacy Supplement with Clinical Data to Support 07/02/2013
NASACORT AQ
(NDA # 020468)

034 TRIAMCINOLONE ACETONIDE SANOFI AVENTIS US Efficacy Supplement with Clinical Data to Support 07/02/2013
SPRIX
(NDA # 022382)

007 KETOROLAC TROMETHAMINE LUITPOLD Manufacturing Change or Addition 07/02/2013
ZIANA
(NDA # 050802)

014 CLINDAMYCIN PHOSPHATE; TRETINOIN MEDICIS Manufacturing Change or Addition 07/02/2013
ROSUVASTATIN CALCIUM
(ANDA # 079161)

000 ROSUVASTATIN CALCIUM MYLAN PHARMA Tentative Approval 07/02/2013
PEGASYS
(BLA # 103964)

5245 PEGINTERFERON ALFA-2A HOFFMAN-LA ROCHE Labeling Revision 07/02/2013
ACTEMRA
(BLA # 125276)

075 TOCILIZUMAB GENENTECH Labeling Revision 07/02/2013
SUBLIMAZE PRESERVATIVE FREE
(NDA # 016619)

034 FENTANYL CITRATE AKORN Labeling Revision 07/03/2013
TENEX
(NDA # 019032)

021 GUANFACINE HYDROCHLORIDE PROMIUS PHARMA Labeling Revision 07/03/2013
PERIOCHIP
(NDA # 020774)

013 CHLORHEXIDINE GLUCONATE DEXCEL PHARMA Manufacturing Change or Addition 07/03/2013
GEODON
(NDA # 020825)

041 ZIPRASIDONE HYDROCHLORIDE PFIZER Labeling Revision 07/03/2013
GEODON
(NDA # 020919)

027 ZIPRASIDONE MESYLATE PFIZER Labeling Revision 07/03/2013
BENICAR
(NDA # 021286)

027 OLMESARTAN MEDOXOMIL DAIICHI SANKYO Labeling Revision 07/03/2013
OXYTROL
(NDA # 021351)

007 OXYBUTYNIN WATSON LABS (UTAH) Manufacturing Change or Addition 07/03/2013
GEODON
(NDA # 021483)

007 ZIPRASIDONE HYDROCHLORIDE PFIZER INC Labeling Revision 07/03/2013
BENICAR HCT
(NDA # 021532)

022 HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL DAIICHI SANKYO Labeling Revision 07/03/2013
AZOR
(NDA # 022100)

022 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL DAIICHI SANKYO Labeling Revision 07/03/2013
CAPRELSA
(NDA # 022405)

004 VANDETANIB IPR PHARMS INC Labeling Revision 07/03/2013
GABAPENTIN
(ANDA # 076672)

000 GABAPENTIN TARO Approval 07/03/2013
PROLIA
(BLA # 125320)

113 DENOSUMAB AMGEN Labeling Revision 07/03/2013
XGEVA
(BLA # 125320)

113 DENOSUMAB AMGEN Labeling Revision 07/03/2013
TRIBENZOR
(NDA # 200175)

014 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL DAIICHI SANKYO Manufacturing Change or Addition 07/03/2013
TRIBENZOR
(NDA # 200175)

015 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL DAIICHI SANKYO Labeling Revision 07/03/2013
ZELBORAF
(NDA # 202429)

002 VEMURAFENIB HOFFMANN LA ROCHE Labeling Revision 07/03/2013
ZELBORAF
(NDA # 202429)

003 VEMURAFENIB HOFFMANN LA ROCHE Labeling Revision 07/03/2013
ZOLEDRONIC ACID
(NDA # 204016)

000 ZOLEDRONIC ACID HOSPIRA INC Tentative Approval 07/03/2013
ZUBSOLV
(NDA # 204242)

000 BUPRENORPHINE; NALOXONE OREXO AB Approval 07/03/2013
DILAUDID
(NDA # 019892)

023 HYDROMORPHONE HYDROCHLORIDE PURDUE PHARM PRODS Manufacturing Change or Addition 07/05/2013
SARAFEM
(NDA # 021860)

006 FLUOXETINE HYDROCHLORIDE WARNER CHILCOTT LLC Labeling Revision 07/05/2013
SARAFEM
(NDA # 021860)

007 FLUOXETINE HYDROCHLORIDE WARNER CHILCOTT LLC Labeling Revision 07/05/2013
SARAFEM
(NDA # 021860)

008 FLUOXETINE HYDROCHLORIDE WARNER CHILCOTT LLC Labeling Revision 07/05/2013
SARAFEM
(NDA # 021860)

009 FLUOXETINE HYDROCHLORIDE WARNER CHILCOTT LLC Labeling Revision 07/05/2013
DONEPEZIL HYDROCHLORIDE
(ANDA # 202114)

000 DONEPEZIL HYDROCHLORIDE ALVOGEN PINE BROOK Approval 07/05/201
Featured stocks: Coffee Shoppe
For conservative debate: "Keeping it Real"
Game Changing stock $SHMP

Scroll down for more posts ▼

Top 10 Most Recent News Articles

F.N.B. Q3 2026 Earnings: Solid Growth Continues

Updated Category News Views 5

F.N.B. Stays the Course with Strong Q3 2026 Ever heard the phrase “slow and steady wins the race?” That seems to be the mantra over at F.N.B. Corporation (NYSE: FNB) as they roll out their Q3 2026 earnings. Now, they aren't breaking any land speed records, but what they are doing is consistently stepping up their game, quarter by quarter, like clockwork. Drilling Down...

Continue Reading
Ryan Stills: Vegan Powerlifter Defies Odds, Wins Sixth World Title

Updated Category News Views 11

Ryan Stills: A Comeback Story for the Ages Ryan Stills isn't just lifting weights; he's lifting the entire perception of what's possible after a heavy surgical setback. We're talking about a guy who stared down a hemi-shoulder replacement—a career ender for many—and came out the other side with a whole new set of gold medals. Two years ago, some might have written him...

Continue Reading
Netcapital Faces Securities Fraud Claims: Key Investor Notes

Updated Category News Views 5

Netcapital Under Fire: The Suit Unfolds You ever see a stock go through such highs and lows that you wish you had popcorn on standby? Well, that's where Netcapital Inc. (NASDAQ: NCPL) is sitting right now, in the midst of a class action lawsuit that's got investors' heads spinning. The accusations are serious: false and misleading statements about revenues that seem to...

Continue Reading
Alaska LNG Project Boosted by Strategic Positioning

Updated Category News Views 9

Alaska LNG: Right Place, Right Time Someone bring out the confetti, because Paul Sullivan, Co-Chairman of Gastech, is celebrating Alaska LNG like it's 1999. And for good reason. If Alaska ever played its cards right, now's the moment according to the industry veteran. After Gastech 2026 wrapped its events in Bangkok last month, Sullivan laid out why the stars are aligning...

Continue Reading
Spooky Suds: House of Horror Meets El Car Wash

Updated Category News Views 12

A Haunted Wash Awaits Miami Drivers Picture this: you're cruising down West Flagler on a regular Wednesday evening, but tonight, you're not just rolling in for a rinse. Nope, this Wednesday night, the wash tunnel at El Car Wash gets downright spooky. It's getting a haunted house makeover with scare actors from the House of Horror. When a Car Wash Becomes a Haunted...

Continue Reading
Veteran Team Fuels Misunderstood Brands' Bold Expansion

Updated Category News Views 8

Adding Heavyweights to Catalyze Growth Imagine you're Misunderstood Brands, prepping your artillery before charging into the battleground of national chains. What do you do? You double down strategically by rallying the best industry minds around. Announced on October 15, 2026, this company's concocted a dream team of beverage veterans as they steer their products—like...

Continue Reading
BETR's Legal Clash: Investor Action Deadline Nears

Updated Category News Views 8

BETR's Woes in the Legal Spotlight Investors who’ve been keeping an eye on Better Home & Finance Holding Company—trading as BETR on NASDAQ—might wanna pinch themselves. Not every day do you see a class action lawsuit waiting on the horizon like this one. The folks over at Schall, Brown & Schwartz LLP, those wily veterans in shareholder rights litigation, are...

Continue Reading
Navigating the Nitty-Gritty of Cabin Rental Management

Updated Category News Views 9

The Real Elbow Grease Behind Cabin Management Ever imagined what it’d take to keep a vacation rental cabin running like a tight ship? Well, Nathan Fitts breaks it down real clear-like. The guy's seen it all in Blue Ridge, Georgia, which isn't just about scenic views—there's serious business brewing behind that cabin charm. More Than Just Fluffing Pillows Turns out,...

Continue Reading
Standex's New Financial Lead: Stoddard Takes Helm

Updated Category News Views 9

New Financial Captain Aboard Standex's Ship Alright, here's something that'll have investors nodding along with interest: Standex International has just named Samantha L. Stoddard as their incoming Chief Financial Officer and Treasurer, effective December 1, 2026. Now, Standex isn't some scrappy upstart. We're talking about a veteran manufacturer intricately working...

Continue Reading
CMS Proposal Sparks Controversy in Lab Certification

Updated Category News Views 8

A New Contender in the Battle Over Lab Standards Here's what’s heating up in the realm of clinical laboratories: A proposed shift by the Centers for Medicare & Medicaid Services (CMS) that reeks of cutting corners, if you ask the folks at the Association for Diagnostics & Laboratory Medicine (ADLM). They’re banging the drums against CMS's idea to nix the board...

Continue Reading

Top 5 Most Recently Viewed Articles

Watsco Increases Annual Dividend by 11% Reflecting Growth

Updated Category News Views 102

Watsco Announces Dividend Increase Watsco, Inc. has recently made headlines by announcing an impressive 11% increase in its annual dividend, raising it to $12.00 per share. This increase will be applicable to all outstanding shares of its Common and Class B common stock. The decision indicates a positive outlook and will take effect with the upcoming quarterly dividend...

Continue Reading
JumpCloud Takes the Lead in IT Management with G2 Recognition

Updated Category News Views 67

JumpCloud Excels with a Record Number of G2 Awards In a remarkable achievement, JumpCloud Inc. has emerged as a leader in 119 G2 Winter 2024 Grid Reports. This accolade comes after the company received over 2,950 reviews from G2 users, highlighting its strength in delivering exceptional IT management solutions. The G2 Grid Reports evaluate products based on user feedback...

Continue Reading
Brooke Rollins and Controversies in Agriculture Policies

Updated Category News Views 693

Brooke Rollins: A New Face at the USDA President Donald Trump's choice to lead the Agriculture Department, Brooke Rollins (NYSE: ROL), has drawn significant attention due to her leadership of an organization that has consistently opposed ethanol mandates and farm subsidies. These are crucial areas she may influence if confirmed, raising eyebrows among lawmakers and...

Continue Reading
Traws Pharma's Breakthrough in H5N1 Treatment Development

Updated Category News Views 113

Innovation in Treating H5N1 Bird Flu by Traws Pharma Traws Pharma, Inc. (NASDAQ: TRAW), a clinical-stage biopharmaceutical company known for developing therapies for respiratory viral diseases, has recently made notable advancements with its investigational treatment, tivoxavir marboxil. This one-dose therapy is being developed specifically for the treatment and...

Continue Reading
Standard Motor Products Unveils Enhanced Corporate Website for Investors

Updated Category News Views 78

Standard Motor Products Launches New Corporate Website Standard Motor Products, Inc. (NYSE: SMP) is excited to unveil its newly designed corporate website. This launch aims to provide enhanced resources for investors and streamline access to vital company information. Collaborating closely with Scandia, a top digital and web development agency, the site has undergone...

Continue Reading