Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008248
Company: BAXTER HLTHCARE CORP

Products on NDA 008248

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
WYAMINE SULFATE	MEPHENTERMINE SULFATE	EQ 30MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
WYAMINE SULFATE	MEPHENTERMINE SULFATE	EQ 15MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 008248

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/1951	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
05/31/1988	SUPPL-7	Labeling		Label is not available on this site.
10/23/1985	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
02/17/1993	SUPPL-5	Labeling		Label is not available on this site.
06/07/1978	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.