Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086010
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET; ORAL Prescription AB 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
04/10/1978 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
07/02/1993 SUPPL-55 Labeling

Label is not available on this site.

05/07/2002 SUPPL-53 Labeling

Label is not available on this site.

01/29/2001 SUPPL-52 Labeling

Label is not available on this site.

03/12/1999 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-47 Labeling

Label is not available on this site.

04/24/1995 SUPPL-46 Labeling

Label is not available on this site.

06/01/1995 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

11/24/1993 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

11/14/1991 SUPPL-41 Labeling

Label is not available on this site.

08/17/1989 SUPPL-40 Bioequivalence

Label is not available on this site.

08/17/1989 SUPPL-39 Bioequivalence

Label is not available on this site.

07/11/1989 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

07/11/1989 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

02/18/1988 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/02/1986 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

11/23/1984 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

06/15/1984 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

01/21/1983 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

01/21/1983 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

AMITRIPTYLINE HYDROCHLORIDE

TABLET; ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET; ORAL Prescription No AB 086010 MYLAN

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