Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204736

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ACIPHEX SPRINKLE (RABEPRAZOLE SODIUM)
5MG
Marketing Status: Discontinued
Active Ingredient: RABEPRAZOLE SODIUM
Proprietary Name: ACIPHEX SPRINKLE
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204736
Product Number: 001
Approval Date: Mar 26, 2013
Applicant Holder Full Name: AYTU BIOSCIENCE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ACIPHEX SPRINKLE (RABEPRAZOLE SODIUM)
10MG
Marketing Status: Discontinued
Active Ingredient: RABEPRAZOLE SODIUM
Proprietary Name: ACIPHEX SPRINKLE
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204736
Product Number: 002
Approval Date: Mar 26, 2013
Applicant Holder Full Name: AYTU BIOSCIENCE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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