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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 074728

LEUPROLIDE ACETATE (LEUPROLIDE ACETATE)
1MG/0.2ML
Marketing Status: Prescription
Active Ingredient: LEUPROLIDE ACETATE
Proprietary Name: LEUPROLIDE ACETATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1MG/0.2ML
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A074728
Product Number: 001
Approval Date: Aug 4, 1998
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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