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Posted On: 02/12/2024 11:25:36 AM
Post# of 8446
Hawk05 post (re: opioids) from the “other board”
I won’t pretend to know what this action means. Took place on Oct 4th, 2023. How much of the total output for Dr. Reddy is affected? What might be the politics behind it or the ramifications of this action? Might this benefit BIEL in some way? This Indian company rakes in billions. I wonder what their market share is?
Here are some links for Dr Reddy’s Lab., Inc.
https://www.drreddys.com/
https://www.drreddysusa.com/
https://en.wikipedia.org/wiki/Dr._Reddy%27s_Laboratories
The Food and Drug Administration (FDA or the Agency) is withdrawing approval of 11 abbreviated new drug applications (ANDAs) from Dr. Reddy's Laboratories, Inc. The applicant notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Oxycodone and Acetaminophen Tablets, 3.25 milligrams (mg); 2.5 mg, 325 mg; 5 mg, 325 mg; 7.5 mg, 325 mg; 10 mg, 500 mg; 7.5 mg, 650 mg; 10 mgDr. Reddy's Laboratories, Inc., U.S. Agent for Dr. Reddy's Laboratories SA, 107 College Rd. East, Princeton NJ 08540.ANDA 091313Oxycodone Hydrochloride (HCl) Tablets, 5 mg, 10 mg, 15 mg, 20 mg, 30 mgDo.ANDA 091670Oxycodone and Aspirin Tablets, 325 mg; 4.8355 mgDo.ANDA 203107Oxycodone HCl Capsules, 5 mgDo.ANDA 203335Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, 325 mg; 50 mg; 40 mg; 30 mgDo.ANDA 203807Clozapine Tablets, 25 mg, 50 mg, 100 mg, 200 mgDo.ANDA 204092Oxycodone HCl Oral Solution 100 mg/5 millilitersDo.ANDA 205386Morphine Sulfate Extended-Release Tablets, 15 mg, 30 mg, 60 mg, 100 mgDo.ANDA 206329Fentanyl Citrate Tablets, Equivalent to (EQ) 0.1 mg base, EQ 0.2 mg base, EQ 0.3 mg base, EQ 0.4 mg base, EQ 0.6 mg base, EQ 0.8 mg baseDo.ANDA 206953Buprenorphine HCl and Naloxone HCI Tablets, EQ 2 mg base, EQ 0.5 mg base; EQ 8 mg base, EQ 2 mg baseDo.ANDA 207270Morphine Sulfate Tablets, 15 mg,
https://www.federalregister.gov/documents/202...plications
Hope for the best, Prepare for the worst.
"Sic parvis magma" - Greatness from small beginnings
All the best, WBeacham
I won’t pretend to know what this action means. Took place on Oct 4th, 2023. How much of the total output for Dr. Reddy is affected? What might be the politics behind it or the ramifications of this action? Might this benefit BIEL in some way? This Indian company rakes in billions. I wonder what their market share is?
Here are some links for Dr Reddy’s Lab., Inc.
https://www.drreddys.com/
https://www.drreddysusa.com/
https://en.wikipedia.org/wiki/Dr._Reddy%27s_Laboratories
The Food and Drug Administration (FDA or the Agency) is withdrawing approval of 11 abbreviated new drug applications (ANDAs) from Dr. Reddy's Laboratories, Inc. The applicant notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Oxycodone and Acetaminophen Tablets, 3.25 milligrams (mg); 2.5 mg, 325 mg; 5 mg, 325 mg; 7.5 mg, 325 mg; 10 mg, 500 mg; 7.5 mg, 650 mg; 10 mgDr. Reddy's Laboratories, Inc., U.S. Agent for Dr. Reddy's Laboratories SA, 107 College Rd. East, Princeton NJ 08540.ANDA 091313Oxycodone Hydrochloride (HCl) Tablets, 5 mg, 10 mg, 15 mg, 20 mg, 30 mgDo.ANDA 091670Oxycodone and Aspirin Tablets, 325 mg; 4.8355 mgDo.ANDA 203107Oxycodone HCl Capsules, 5 mgDo.ANDA 203335Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, 325 mg; 50 mg; 40 mg; 30 mgDo.ANDA 203807Clozapine Tablets, 25 mg, 50 mg, 100 mg, 200 mgDo.ANDA 204092Oxycodone HCl Oral Solution 100 mg/5 millilitersDo.ANDA 205386Morphine Sulfate Extended-Release Tablets, 15 mg, 30 mg, 60 mg, 100 mgDo.ANDA 206329Fentanyl Citrate Tablets, Equivalent to (EQ) 0.1 mg base, EQ 0.2 mg base, EQ 0.3 mg base, EQ 0.4 mg base, EQ 0.6 mg base, EQ 0.8 mg baseDo.ANDA 206953Buprenorphine HCl and Naloxone HCI Tablets, EQ 2 mg base, EQ 0.5 mg base; EQ 8 mg base, EQ 2 mg baseDo.ANDA 207270Morphine Sulfate Tablets, 15 mg,
https://www.federalregister.gov/documents/202...plications
Quote:
THESE are the times that try men’s souls. The summer soldier and the sunshine patriot will, in this crisis, shrink from the service of their country; but he that stands it now, deserves the love and thanks of man and woman.
Hope for the best, Prepare for the worst.
"Sic parvis magma" - Greatness from small beginnings
All the best, WBeacham
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