promethazine hcl tablets

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33 documents for promethazine hcl tablets

- Withdrawal of Approval of 27 New Drug Applications and 58 Abbreviated New Drug Applications:
...NDA 6-008. Mesantoin (mephenytoin) Tablets. Novartis Pharmaceuticals Corp., One Health. Plaza...Do. ANDA 85-146. Promethazine HCl Tablets, 25 mg and 50 Do. mg. ANDA 85-934. But...
- FR, July 21, 2010
- Notices
- Food and Drug Administration
- Human drugs: Drug products withdrawn from sale for reasons other than safety or effectiveness PHENERGAN (Promethazine hydrochloride) tablets, 12.5 milligrams and 50 milligrams,
- FR, July 14, 2006
- Notices
- Food and Drug Administration
- Able Laboratories Reports First Quarter 2003 Results.
... approvals in April 2003 including Promethazine HCL Suppositories, USP 12.5mg and 25mg and Lithiumm Carbonate Extended-Release Tablets, USP 300mg - the Company's first first-to-market p...
- Business Wire
- May 06, 2003

- Apothecon et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications
...Injection. NDA 7-935. Phenergan (promethazine HCl) Tablets Wyeth Pharmaceuticals, Inc., P.O. Box...
- FR, February 11, 2009
- Notices
- Food and Drug Administration
- FDA preemption of drug and device labeling: who should decide what goes on a drug label?
... had ingested unlabeled thalidomide tablets under the then unregulated clinical testing. (27) ...--Phenergan[R]--is also known as promethazine and is an antihistamine used to treat allergy symp...
- Health Matrix. Journal of Law-Medicine
- Vol. 21 Nbr. 2, March 2011
- Human drugs: New drug applications Able Laboratories, Inc.; approval withdrawn,
...Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 milligrams (mg)/325 mg/40 mg. 40-394. Buta...40-449. Promethazine HCl Suppositories USP, 50 mg. 40-464. Hydrocodone ...
- FR, January 19, 2006
- Notices
- Food and Drug Administration
- Withdrawal of Approval of 92 New Drug and 49 Abbreviated New Drug Applications: Novartis Pharmaceuticals Corp. et al.
...Do. mesylates) Sublingual. Tablets. NDA 9-509. Aramine (metaraminol. Merck & Co., Inc...ANDA 83-838. Promethazine HCl Injection Do. USP. ANDA 84-074. Bethanechol Ch...
- FR, May 19, 2009
- Notices
- Food and Drug Administration
- Not Withdrawn From Sale for Reasons of Safety or Effectiveness: TAPAZOLE Tablets and 18 Other Drug Products
...37620. 7-935. PHENERGAN (promethazine. Wyeth Pharmaceuticals,Inc., hydrochloride (HCl))....
- FR, April 28, 2008
- Notices
- Food and Drug Administration
- Human drugs: Schering Corp. et al.; approval withdrawn,
...Oreton Methyl (methyltestosterone) Tablets, Schering Corp., 2000 Galloping Hill Rd., 10 milli...ANDA 84-214. Promethazine HCl Tablets USP, 25 mg. Do. ANDA 84-340. Triamcino...
- FR, August 16, 2001
- Notices
- Food and Drug Administration
- Withdrawal of Approval of 70 New Drug Applications and 97 Abbreviated New Drug Applications:
...Co., P.O. Box 4000,. Codeine Tablets. Princeton, NJ 08543- 4000. NDA 008248......... Wy...ANDA 085385......... Promethazine HCl. Do. Syrup, 25 mg/5 mL. ANDA 085388......... P...
- FR, June 08, 2011
- Notices
- Food and Drug Administration