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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089402
Company: MUTUAL PHARM
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
07/14/1987 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
11/21/2007 SUPPL-32 Labeling

Label is not available on this site.

06/29/2007 SUPPL-31 Labeling

Label is not available on this site.

07/16/2007 SUPPL-30 Labeling

Label is not available on this site.

08/26/2005 SUPPL-24 Labeling

Label is not available on this site.

05/05/2005 SUPPL-23 Labeling

Label is not available on this site.

09/30/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/22/2001 SUPPL-13 Labeling

Label is not available on this site.

07/05/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2000 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

12/05/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/22/1995 SUPPL-6 Labeling

Label is not available on this site.

06/22/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/16/1993 SUPPL-3 Labeling

Label is not available on this site.

05/15/1992 SUPPL-2 Labeling

Label is not available on this site.

02/27/1992 SUPPL-1 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 202446 ACCORD HLTHCARE
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 216243 LEADING
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 213999 MANKIND PHARMA
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 089402 MUTUAL PHARM
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription Yes AB 085968 SANDOZ
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 089399 SUN PHARM INDS INC
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 214548 UNICHEM
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 210086 ZYDUS PHARMS
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