Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086011
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG 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
05/07/2002 SUPPL-41 Labeling

Label is not available on this site.

01/29/2001 SUPPL-40 Labeling

Label is not available on this site.

03/12/1999 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-35 Labeling

Label is not available on this site.

04/24/1995 SUPPL-34 Labeling

Label is not available on this site.

06/01/1995 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

11/24/1993 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

07/02/1993 SUPPL-29 Labeling

Label is not available on this site.

11/14/1991 SUPPL-27 Labeling

Label is not available on this site.

12/28/1990 SUPPL-26 Labeling

Label is not available on this site.

01/31/1990 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/18/1988 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/02/1986 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/05/1985 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/23/1984 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

01/21/1983 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/21/1983 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

AMITRIPTYLINE HYDROCHLORIDE

TABLET; ORAL; 75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET; ORAL Prescription No AB 086011 MYLAN

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