Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070337
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 25MG;2MG TABLET; ORAL Prescription 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
11/10/1988 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
05/07/2002 SUPPL-12 Labeling

Label is not available on this site.

02/25/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/04/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/28/1995 SUPPL-8 Labeling

Label is not available on this site.

10/05/1993 SUPPL-7 Labeling

Label is not available on this site.

09/01/1993 SUPPL-6 Labeling

Label is not available on this site.

10/22/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/05/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/31/1990 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/01/1989 SUPPL-1 Labeling

Label is not available on this site.

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