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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212319

ATROPINE (AUTOINJECTOR) (ATROPINE)
EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML)
Marketing Status: Discontinued
Active Ingredient: ATROPINE
Proprietary Name: ATROPINE (AUTOINJECTOR)
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR
Strength: EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N212319
Product Number: 001
Approval Date: Jul 9, 2018
Applicant Holder Full Name: RAFA LABORATORIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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