Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086158
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG 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
04/26/1978 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
05/07/2002 SUPPL-44 Labeling

Label is not available on this site.

01/29/2001 SUPPL-43 Labeling

Label is not available on this site.

03/12/1999 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-38 Labeling

Label is not available on this site.

04/24/1995 SUPPL-37 Labeling

Label is not available on this site.

06/01/1995 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

11/24/1993 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/02/1993 SUPPL-32 Labeling

Label is not available on this site.

11/14/1991 SUPPL-30 Labeling

Label is not available on this site.

07/24/1989 SUPPL-29 Bioequivalence

Label is not available on this site.

08/17/1989 SUPPL-28 Bioequivalence

Label is not available on this site.

07/11/1989 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

07/11/1989 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/18/1988 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/02/1986 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/26/1984 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/15/1984 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/19/1983 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/19/1983 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

AMITRIPTYLINE HYDROCHLORIDE

TABLET; ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET; ORAL Prescription No AB 086158 MYLAN

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