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FDA ANDA · ANDA089497

IMIPRAMINE HYDROCHLORIDE

Sponsor: PAR PHARM

APPLICATION
ANDA089497
TYPE
ANDA
ORIGINAL APPROVAL
1987-07-14
LATEST ACTION
1997-10-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IMIPRAMINE HYDROCHLORIDEDiscontinued
IMIPRAMINE HYDROCHLORIDE 25MG · TABLET · ORAL

Approval history

1997-10-02Manufacturing (CMC) · Supplement 12AP
1996-03-25Manufacturing (CMC) · Supplement 10AP
1996-03-25Manufacturing (CMC) · Supplement 11AP
1996-03-25Labeling · Supplement 9AP
1995-10-23Labeling · Supplement 8AP
1993-11-05Labeling · Supplement 7AP
1991-01-07Labeling · Supplement 6AP
1988-08-19Manufacturing (CMC) · Supplement 3AP
1988-08-19Manufacturing (CMC) · Supplement 1AP
1988-08-19Manufacturing (CMC) · Supplement 4AP
1987-07-14OriginalAP
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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