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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo
Federal Trade Commission
Johnson and Johnson
Harvard Business School

Generated: July 23, 2017

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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 eleven drug master file entries for this compound. Two 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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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Harvard Business School
Johnson and Johnson
Express Scripts
Federal Trade Commission

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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