Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088430
Company: UPSHER SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG 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
03/27/1984 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
10/18/1989 SUPPL-19 Labeling

Label is not available on this site.

08/24/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/24/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/24/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/18/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/09/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/03/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/08/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/08/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/08/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

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