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Serving leading biopharmaceutical companies globally:

Fish and Richardson
QuintilesIMS
Julphar
Boehringer Ingelheim
Chubb
Deloitte
Cipla
Moodys
US Army
UBS

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200271

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NDA 200271 describes HYDROXYPROGESTERONE CAPROATE, which is a drug marketed by Akorn, Allergan Sales Llc, and Aspen Global Inc, and is included in three NDAs. It is available from two suppliers. Additional details are available on the HYDROXYPROGESTERONE CAPROATE profile page.

The generic ingredient in HYDROXYPROGESTERONE CAPROATE is hydroxyprogesterone caproate. There are eleven 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 200271
Tradename:HYDROXYPROGESTERONE CAPROATE
Applicant:Aspen Global Inc
Ingredient:hydroxyprogesterone caproate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200271
Ingredient-typeProgesterone Congeners
Suppliers and Packaging for NDA: 200271
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYPROGESTERONE CAPROATE hydroxyprogesterone caproate INJECTABLE;INJECTION 200271 ANDA ANI Pharmaceuticals, Inc. 62559-540 62559-540-15 1 VIAL, GLASS in 1 PACKAGE (62559-540-15) > 5 mL in 1 VIAL, GLASS
HYDROXYPROGESTERONE CAPROATE hydroxyprogesterone caproate INJECTABLE;INJECTION 200271 ANDA Mylan Institutional LLC 67457-886 67457-886-05 1 VIAL, MULTI-DOSE in 1 CARTON (67457-886-05) > 5 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength250MG/ML
Approval Date:Aug 24, 2015TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Chubb
Moodys
Federal Trade Commission
AstraZeneca
Daiichi Sankyo
Merck
US Department of Justice
Cipla
Accenture

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