Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086157
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 10MG 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-47 Labeling

Label is not available on this site.

01/29/2001 SUPPL-46 Labeling

Label is not available on this site.

03/12/1999 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-41 Labeling

Label is not available on this site.

04/24/1995 SUPPL-40 Labeling

Label is not available on this site.

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

Label is not available on this site.

06/01/1995 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

11/24/1993 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

07/02/1993 SUPPL-35 Labeling

Label is not available on this site.

11/14/1991 SUPPL-33 Labeling

Label is not available on this site.

12/28/1990 SUPPL-32 Labeling

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-26 Manufacturing (CMC)

Label is not available on this site.

05/24/1984 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/15/1984 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/21/1983 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/24/1983 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/24/1983 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

AMITRIPTYLINE HYDROCHLORIDE

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 086157 MYLAN

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