Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086009
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription AB No No
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB No No
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription AB No No
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription AB No No
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription AB No No
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 150MG 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
04/25/2016 SUPPL-67 Labeling-Medication Guide

Label is not available on this site.

07/17/2014 SUPPL-66 Labeling-Package Insert

Label is not available on this site.

11/21/2007 SUPPL-61 Labeling

Label is not available on this site.

04/14/2008 SUPPL-59 Labeling

Label is not available on this site.

07/11/2007 SUPPL-58 Labeling

Label is not available on this site.

07/08/2005 SUPPL-51 Labeling

Label is not available on this site.

05/07/2002 SUPPL-49 Labeling

Label is not available on this site.

01/29/2001 SUPPL-48 Labeling

Label is not available on this site.

03/12/1999 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-43 Labeling

Label is not available on this site.

04/24/1995 SUPPL-42 Labeling

Label is not available on this site.

06/01/1995 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

11/24/1993 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

07/02/1993 SUPPL-37 Labeling

Label is not available on this site.

11/14/1991 SUPPL-35 Labeling

Label is not available on this site.

08/17/1989 SUPPL-34 Bioequivalence

Label is not available on this site.

08/17/1989 SUPPL-33 Bioequivalence

Label is not available on this site.

07/11/1989 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

07/11/1989 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

02/18/1988 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

07/02/1986 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

11/23/1984 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/15/1984 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/19/1983 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/19/1983 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/04/1982 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

AMITRIPTYLINE HYDROCHLORIDE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 202446 ACCORD HLTHCARE
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 089400 MUTUAL PHARM
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 086009 MYLAN
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 085968 SANDOZ
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040218 VINTAGE PHARMS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 210086 ZYDUS PHARMS USA INC

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 202446 ACCORD HLTHCARE
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 086009 MYLAN
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 085969 SANDOZ
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 040218 VINTAGE PHARMS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 210086 ZYDUS PHARMS USA INC

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 202446 ACCORD HLTHCARE
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 086009 MYLAN
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 085966 SANDOZ
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040218 VINTAGE PHARMS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 210086 ZYDUS PHARMS USA INC

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 202446 ACCORD HLTHCARE
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 086009 MYLAN
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 085971 SANDOZ
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 040218 VINTAGE PHARMS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 210086 ZYDUS PHARMS USA INC

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 202446 ACCORD HLTHCARE
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 089402 MUTUAL PHARM
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 086009 MYLAN
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 085967 SANDOZ
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 040218 VINTAGE PHARMS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 210086 ZYDUS PHARMS USA INC

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 202446 ACCORD HLTHCARE
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 086009 MYLAN
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 085970 SANDOZ
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 040218 VINTAGE PHARMS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 210086 ZYDUS PHARMS USA INC

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