Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084093
Company: OAK PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEMBUTAL SODIUM PENTOBARBITAL SODIUM 50MG CAPSULE;ORAL 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
01/14/1975 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
02/06/2019 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/20/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/03/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/22/1992 SUPPL-8 Labeling

Label is not available on this site.

03/10/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

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