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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020508

LAC-HYDRIN (AMMONIUM LACTATE)
EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMMONIUM LACTATE
Proprietary Name: LAC-HYDRIN
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020508
Product Number: 001
Approval Date: Aug 29, 1996
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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