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Generated: June 20, 2018

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Details for New Drug Application (NDA): 021945

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NDA 021945 describes MAKENA (AUTOINJECTOR), which is a drug marketed by Amag Pharma Usa and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the MAKENA (AUTOINJECTOR) profile page.

The generic ingredient in MAKENA (AUTOINJECTOR) is hydroxyprogesterone caproate. There are twelve 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 021945
Tradename:MAKENA (AUTOINJECTOR)
Applicant:Amag Pharma Usa
Ingredient:hydroxyprogesterone caproate
Patents:8
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
MAKENA hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 021945 NDA AMAG Pharmaceuticals, Inc. 64011-243 N 64011-243-01
MAKENA PRESERVATIVE FREE hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 021945 NDA AMAG Pharmaceuticals, Inc. 64011-243 N 64011-243-01

Profile 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:TO REDUCE THE RISK OF PRETERM BIRTH IN WOMEN WITH SINGLETON PREGNANCY WHO HAVE A HISTORY OF SINGLETON SPONTANEOUS PRETERM BIRTH

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULARStrength250MG/ML (250MG/ML)
Approval Date:Feb 19, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 3, 2018
Regulatory Exclusivity Use:TO REDUCE THE RISK OF PRETERM BIRTH IN WOMEN WITH SINGLETON PREGNANCY WHO HAVE A HISTORY OF SINGLETON SPONTANEOUS PRETERM BIRTH

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength275MG/1.1ML (250MG/ML)
Approval Date:Feb 14, 2018TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 4, 2026Product Flag?YSubstance Flag?Delist Request?

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