Last Updated: November 13, 2026

Details for New Drug Application (NDA): 020508

NDA 020508 describes LAC-HYDRIN, which is a drug marketed by Sun Pharm Inds Inc and is included in two NDAs. Additional details are available on the LAC-HYDRIN profile page.

The generic ingredient in LAC-HYDRIN is ammonium lactate. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the ammonium lactate profile page.

Summary for 020508

Tradename:	LAC-HYDRIN
Applicant:	Sun Pharm Inds Inc
Ingredient:	ammonium lactate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	EQ 12% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 29, 1996	TE:		RLD:	Yes

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