Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084487
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
04/09/1982 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
09/17/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/14/1991 SUPPL-19 Labeling

Label is not available on this site.

09/22/1989 SUPPL-18 Labeling

Label is not available on this site.

04/05/1989 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/30/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/03/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/22/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/08/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/22/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/22/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/02/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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