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FDA NDA · NDA020508

LAC-HYDRIN

Sponsor: SUN PHARM INDS INC

APPLICATION
NDA020508
TYPE
NDA
ORIGINAL APPROVAL
1996-08-29
LATEST ACTION
2004-12-13
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

LAC-HYDRIN · ReferenceDiscontinued
AMMONIUM LACTATE EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL

Approval history

2004-12-13Labeling · Supplement 6 · standard — Label ↗AP
2000-08-25Efficacy · Supplement 5 · unknown — Review ↗AP
1999-07-19Manufacturing (CMC) · Supplement 4 · standardAP
1998-05-13Manufacturing (CMC) · Supplement 3 · standardAP
1998-03-21Manufacturing (CMC) · Supplement 2 · standardAP
1996-08-29Type 3 - New Dosage Form · Original · standardAP
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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