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FDA ANDA · ANDA084363

TRIHEXYPHENIDYL HYDROCHLORIDE

Sponsor: WATSON LABS

APPLICATION
ANDA084363
TYPE
ANDA
ORIGINAL APPROVAL
1974-11-26
LATEST ACTION
2001-08-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TRIHEXYPHENIDYL HYDROCHLORIDEPrescription
TRIHEXYPHENIDYL HYDROCHLORIDE 2MG · TABLET · ORAL

Approval history

2001-08-13Manufacturing (CMC) · Supplement 59AP
2001-04-25Manufacturing (CMC) · Supplement 58AP
1997-12-11Manufacturing (CMC) · Supplement 52AP
1997-10-08Manufacturing (CMC) · Supplement 56AP
1997-09-02Manufacturing (CMC) · Supplement 55AP
1997-09-02Manufacturing (CMC) · Supplement 53AP
1997-09-02Manufacturing (CMC) · Supplement 54AP
1991-01-28Manufacturing (CMC) · Supplement 49AP
1988-11-14Labeling · Supplement 44AP
1985-01-28Manufacturing (CMC) · Supplement 39AP
1985-01-28Manufacturing (CMC) · Supplement 38AP
1985-01-28Manufacturing (CMC) · Supplement 40AP
1984-02-09Manufacturing (CMC) · Supplement 36AP
1982-11-30Manufacturing (CMC) · Supplement 35AP
1974-11-26OriginalAP
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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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