U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 083711
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG 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
09/21/1973 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-38 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/1997 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

12/16/1997 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

01/28/1991 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

09/28/1989 SUPPL-31 Labeling

Label is not available on this site.

03/18/1988 SUPPL-27 Labeling

Label is not available on this site.

02/18/1986 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/18/1986 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

12/21/1983 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

PROMETHAZINE HYDROCHLORIDE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 091179 AMNEAL PHARMS NY
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040712 KVK TECH
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040713 KVK TECH
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040622 PRINSTON INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040673 QUAGEN
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription Yes AB 084176 SANDOZ
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 209177 STRIDES PHARMA
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040863 SUN PHARM INDS INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 083711 WATSON LABS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040596 ZYDUS PHARMS USA
Back to Top