Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089402
Company: MUTUAL PHARM

Products on ANDA 089402

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089402

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.

Therapeutic Equivalents for ANDA 089402

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	212654	AIPING PHARM INC
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	086009	AUROBINDO PHARMA USA
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	No	AB	217411	RISING
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	215376	RUBICON RESEARCH
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	218389	UNIQUE PHARM
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	210086	ZYDUS PHARMS