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FDA ANDA · ANDA084364

TRIHEXYPHENIDYL HYDROCHLORIDE

Sponsor: WATSON LABS

APPLICATION
ANDA084364
TYPE
ANDA
ORIGINAL APPROVAL
1974-12-06
LATEST ACTION
2007-06-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TRIHEXYPHENIDYL HYDROCHLORIDEPrescription
TRIHEXYPHENIDYL HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

2007-06-19Manufacturing (CMC) · Supplement 54AP
2001-12-06Manufacturing (CMC) · Supplement 53AP
2001-04-25Manufacturing (CMC) · Supplement 52AP
1997-12-11Manufacturing (CMC) · Supplement 46AP
1997-10-08Manufacturing (CMC) · Supplement 49AP
1997-09-02Manufacturing (CMC) · Supplement 48AP
1997-09-02Manufacturing (CMC) · Supplement 50AP
1997-09-02Manufacturing (CMC) · Supplement 47AP
1991-01-28Manufacturing (CMC) · Supplement 43AP
1988-11-14Labeling · Supplement 38AP
1985-05-28Manufacturing (CMC) · Supplement 34AP
1985-05-28Manufacturing (CMC) · Supplement 33AP
1985-01-22Manufacturing (CMC) · Supplement 32AP
1984-02-09Manufacturing (CMC) · Supplement 30AP
1983-01-18Manufacturing (CMC) · Supplement 29AP
1974-12-06OriginalAP
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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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