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FDA ANDA · ANDA072691

AMOXAPINE

Sponsor: WATSON LABS

APPLICATION
ANDA072691
TYPE
ANDA
ORIGINAL APPROVAL
1992-08-28
LATEST ACTION
2014-07-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

AMOXAPINEPrescription
AMOXAPINE 100MG · TABLET · ORAL
AMOXAPINEPrescription
AMOXAPINE 25MG · TABLET · ORAL
AMOXAPINEPrescription
AMOXAPINE 50MG · TABLET · ORAL
AMOXAPINEPrescription
AMOXAPINE 150MG · TABLET · ORAL

Approval history

2014-07-17Labeling · Supplement 36 · standard — Label ↗AP
2008-04-14Labeling · Supplement 19AP
2007-07-03Labeling · Supplement 17AP
2005-05-05Labeling · Supplement 13AP
2002-10-23Manufacturing (CMC) · Supplement 9AP
2002-05-07Labeling · Supplement 10AP
2001-04-25Manufacturing (CMC) · Supplement 7AP
2001-02-14Labeling · Supplement 8AP
1998-12-09Manufacturing (CMC) · Supplement 5AP
1995-12-13Labeling · Supplement 4AP
1994-02-07Manufacturing (CMC) · Supplement 3AP
1993-10-19Labeling · Supplement 2AP
1993-02-05Labeling · Supplement 1AP
1992-08-28OriginalAP
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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