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FDA NDA · NDA021417

PREMARIN

Sponsor: WYETH PHARMS INC

APPLICATION
NDA021417
TYPE
NDA
ORIGINAL APPROVAL
2003-07-16
LATEST ACTION
2003-07-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PREMARINPrescription
ESTROGENS, CONJUGATED 0.45MG · TABLET · ORAL
PREMARINPrescription
ESTROGENS, CONJUGATED 0.3MG · TABLET · ORAL

Approval history

2003-07-16Type 6 - New Indication (no longer used) · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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