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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204223

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MORPHINE SULFATE (MORPHINE SULFATE)
2MG/ML (2MG/ML)
Marketing Status: Prescription
Active Ingredient: MORPHINE SULFATE
Proprietary Name: MORPHINE SULFATE
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, INTRAVENOUS
Strength: 2MG/ML (2MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204223
Product Number: 001
Approval Date: Oct 30, 2013
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
MORPHINE SULFATE (MORPHINE SULFATE)
4MG/ML (4MG/ML)
Marketing Status: Prescription
Active Ingredient: MORPHINE SULFATE
Proprietary Name: MORPHINE SULFATE
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, INTRAVENOUS
Strength: 4MG/ML (4MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204223
Product Number: 002
Approval Date: Oct 30, 2013
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
MORPHINE SULFATE (MORPHINE SULFATE)
5MG/ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: MORPHINE SULFATE
Proprietary Name: MORPHINE SULFATE
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, INTRAVENOUS
Strength: 5MG/ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204223
Product Number: 003
Approval Date: Oct 30, 2013
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
MORPHINE SULFATE (MORPHINE SULFATE)
8MG/ML (8MG/ML)
Marketing Status: Prescription
Active Ingredient: MORPHINE SULFATE
Proprietary Name: MORPHINE SULFATE
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, INTRAVENOUS
Strength: 8MG/ML (8MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204223
Product Number: 004
Approval Date: Oct 30, 2013
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
MORPHINE SULFATE (MORPHINE SULFATE)
10MG/ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: MORPHINE SULFATE
Proprietary Name: MORPHINE SULFATE
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, INTRAVENOUS
Strength: 10MG/ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204223
Product Number: 005
Approval Date: Oct 30, 2013
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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