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FDA ANDA · ANDA086158

AMITRIPTYLINE HYDROCHLORIDE

Sponsor: MYLAN

APPLICATION
ANDA086158
TYPE
ANDA
ORIGINAL APPROVAL
1978-04-26
LATEST ACTION
2002-05-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 100MG · TABLET · ORAL

Approval history

2002-05-07Labeling · Supplement 44AP
2001-01-29Labeling · Supplement 43AP
1999-03-12Manufacturing (CMC) · Supplement 42AP
1999-03-12Manufacturing (CMC) · Supplement 41AP
1998-02-25Manufacturing (CMC) · Supplement 40AP
1998-02-05Manufacturing (CMC) · Supplement 39AP
1995-06-01Manufacturing (CMC) · Supplement 36AP
1995-06-01Manufacturing (CMC) · Supplement 34AP
1995-06-01Manufacturing (CMC) · Supplement 35AP
1995-06-01Labeling · Supplement 38AP
1995-04-24Labeling · Supplement 37AP
1993-11-24Manufacturing (CMC) · Supplement 33AP
1993-07-02Labeling · Supplement 32AP
1991-11-14Labeling · Supplement 30AP
1989-08-17Bioequivalence · Supplement 28AP
1989-07-24Bioequivalence · Supplement 29AP
1989-07-11Manufacturing (CMC) · Supplement 26AP
1989-07-11Manufacturing (CMC) · Supplement 27AP
1988-02-18Manufacturing (CMC) · Supplement 22AP
1986-07-02Manufacturing (CMC) · Supplement 21AP
1984-11-26Manufacturing (CMC) · Supplement 18AP
1984-06-15Manufacturing (CMC) · Supplement 17AP
1983-01-19Manufacturing (CMC) · Supplement 16AP
1983-01-19Manufacturing (CMC) · Supplement 15AP
1978-04-26OriginalAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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