Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211139

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AMPHETAMINE SULFATE (AMPHETAMINE SULFATE)
5MG Marketing Status: Prescription

Active Ingredient: AMPHETAMINE SULFATE
Proprietary Name: AMPHETAMINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A211139
Product Number: 001
Approval Date: Sep 26, 2018
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

AMPHETAMINE SULFATE (AMPHETAMINE SULFATE)
10MG Marketing Status: Prescription

Active Ingredient: AMPHETAMINE SULFATE
Proprietary Name: AMPHETAMINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A211139
Product Number: 002
Approval Date: Sep 26, 2018
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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