U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 211139

Expand all

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
Back to Top