Drugs@FDA: FDA-Approved Drugs

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

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