Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083426
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/19/1973 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/09/2005 SUPPL-44 Labeling

Label is not available on this site.

12/22/2004 SUPPL-42 Labeling

Label is not available on this site.

04/25/2001 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1998 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

01/28/1991 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

10/18/1989 SUPPL-34 Labeling

Label is not available on this site.

03/29/1989 SUPPL-33 Bioequivalence

Label is not available on this site.

12/13/1983 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/26/1997 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

PROMETHAZINE HYDROCHLORIDE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 091179 AMNEAL PHARMS NY
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040712 KVK TECH
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040622 PRINSTON INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040673 QUAGEN
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 084176 SANDOZ
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 209177 STRIDES PHARMA
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040863 SUN PHARM INDS INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 083426 WATSON LABS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040596 ZYDUS PHARMS USA

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