Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212868

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ATROPINE SULFATE (ATROPINE SULFATE)
0.25MG/5ML (0.05MG/ML)
Marketing Status: Prescription

Active Ingredient: ATROPINE SULFATE
Proprietary Name: ATROPINE SULFATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 0.25MG/5ML (0.05MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212868
Product Number: 001
Approval Date: Jul 26, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ATROPINE SULFATE (ATROPINE SULFATE)
0.5MG/5ML (0.1MG/ML)
Marketing Status: Prescription

Active Ingredient: ATROPINE SULFATE
Proprietary Name: ATROPINE SULFATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 0.5MG/5ML (0.1MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212868
Product Number: 002
Approval Date: Jul 26, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ATROPINE SULFATE (ATROPINE SULFATE)
1MG/10ML (0.1MG/ML)
Marketing Status: Prescription

Active Ingredient: ATROPINE SULFATE
Proprietary Name: ATROPINE SULFATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1MG/10ML (0.1MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212868
Product Number: 003
Approval Date: Jul 26, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information