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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 087708

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE)
0.025MG/5ML;2.5MG/5ML
Marketing Status: Prescription
Active Ingredient: ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Proprietary Name: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 0.025MG/5ML;2.5MG/5ML
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A087708
Product Number: 001
Approval Date: May 3, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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