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FDA NDA · NDA074973

PRIMSOL

Sponsor: PANGEA

APPLICATION
NDA074973
TYPE
NDA
ORIGINAL APPROVAL
2000-01-24
LATEST ACTION
2016-12-21
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

PRIMSOL · ReferenceDiscontinued
TRIMETHOPRIM HYDROCHLORIDE EQ 50MG BASE/5ML · SOLUTION · ORAL

Approval history

2016-12-21Labeling · Supplement 8 · standardLabelAP
2014-09-08Manufacturing (CMC) · Supplement 7 · unknownAP
2001-03-20Manufacturing (CMC) · Supplement 1AP
2000-01-24OriginalReviewAP
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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