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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Fish and Richardson
Boehringer Ingelheim
Johnson and Johnson

Generated: May 20, 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 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 200271
Applicant:Aspen Global Inc
Ingredient:hydroxyprogesterone caproate
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 N 62559-540-15
HYDROXYPROGESTERONE CAPROATE hydroxyprogesterone caproate INJECTABLE;INJECTION 200271 ANDA Mylan Institutional LLC 67457-886 N 67457-886-05

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 hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Boehringer Ingelheim

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