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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204393

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MITIGO (MORPHINE SULFATE)
10MG/ML
Marketing Status: Prescription
Active Ingredient: MORPHINE SULFATE
Proprietary Name: MITIGO
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A204393
Product Number: 001
Approval Date: Jul 16, 2018
Applicant Holder Full Name: PIRAMAL CRITICAL CARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
MITIGO (MORPHINE SULFATE)
25MG/ML
Marketing Status: Prescription
Active Ingredient: MORPHINE SULFATE
Proprietary Name: MITIGO
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 25MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A204393
Product Number: 002
Approval Date: Jul 16, 2018
Applicant Holder Full Name: PIRAMAL CRITICAL CARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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