Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021945

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MAKENA (HYDROXYPROGESTERONE CAPROATE)
1250MG/5ML (250MG/ML) Marketing Status: Prescription

Active Ingredient: HYDROXYPROGESTERONE CAPROATE
Proprietary Name: MAKENA
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR
Strength: 1250MG/5ML (250MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021945
Product Number: 001
Approval Date: Feb 3, 2011
Applicant Holder Full Name: AMAG PHARMA USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MAKENA PRESERVATIVE FREE (HYDROXYPROGESTERONE CAPROATE)
250MG/ML (250MG/ML) Marketing Status: Prescription

Active Ingredient: HYDROXYPROGESTERONE CAPROATE
Proprietary Name: MAKENA PRESERVATIVE FREE
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR
Strength: 250MG/ML (250MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021945
Product Number: 002
Approval Date: Feb 19, 2016
Applicant Holder Full Name: AMAG PHARMA USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MAKENA (AUTOINJECTOR) (HYDROXYPROGESTERONE CAPROATE)
275MG/1.1ML (250MG/ML) Marketing Status: Prescription

Active Ingredient: HYDROXYPROGESTERONE CAPROATE
Proprietary Name: MAKENA (AUTOINJECTOR)
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 275MG/1.1ML (250MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021945
Product Number: 004
Approval Date: Feb 14, 2018
Applicant Holder Full Name: AMAG PHARMA USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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