Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008857
Company: WYETH AYERST

Products on NDA 008857

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 008857

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.