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Details for New Drug Application (NDA): 021945

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NDA 021945 describes MAKENA PRESERVATIVE FREE, which is a drug marketed by Amag Pharma Usa and is included in one NDA. It is available from one supplier. Additional details are available on the MAKENA PRESERVATIVE FREE profile page.

The generic ingredient in MAKENA PRESERVATIVE FREE is hydroxyprogesterone caproate. There are ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the hydroxyprogesterone caproate profile page.

Summary for NDA: 021945

Formulation / Manufacturing:see details

Pharmacology for NDA: 021945

Ingredient-typeProgesterone Congeners

Suppliers and Packaging for NDA: 021945

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
hydroxyprogesterone caproate
SOLUTION;INTRAMUSCULAR 021945 NDA AMAG Pharmaceuticals, Inc. 64011-243 64011-243-01 1 VIAL, GLASS in 1 CARTON (64011-243-01) > 5 mL in 1 VIAL, GLASS
hydroxyprogesterone caproate
SOLUTION;INTRAMUSCULAR 021945 NDA AMAG Pharmaceuticals, Inc. 64011-247 64011-247-02 4 CARTON in 1 TRAY (64011-247-02) > 1 VIAL, GLASS in 1 CARTON > 1 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULARStrength1250MG/5ML (250MG/ML)
Approval Date:Feb 3, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 3, 2018
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULARStrength250MG/ML (250MG/ML)
Approval Date:Feb 19, 2016TE:RLD:Yes

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