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

New Drug Application (NDA): 008857
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENERGAN PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE;INJECTION Discontinued None No No
PHENERGAN PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Discontinued None 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
08/20/1956 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/16/1993 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/21/1993 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/26/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/30/1988 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/06/1987 SUPPL-14 Labeling

Label is not available on this site.

03/04/1987 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/31/1987 SUPPL-12 Labeling

Label is not available on this site.

02/27/1986 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1986 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1998 SUPPL-9 Labeling

Label is not available on this site.

08/08/1979 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1979 SUPPL-7 Labeling

Label is not available on this site.

10/30/1978 SUPPL-6 Labeling

Label is not available on this site.

Back to Top