Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083261
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM PENTOBARBITAL PENTOBARBITAL SODIUM 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
12/19/1973 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
07/30/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/30/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/15/1989 SUPPL-9 Labeling

Label is not available on this site.

04/28/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/12/1983 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/12/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

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