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Serving leading biopharmaceutical companies globally:

Express Scripts
Farmers Insurance
Fish and Richardson

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075528

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NDA 075528 describes CLOMIPHENE CITRATE, which is a drug marketed by Par Pharm and is included in one NDA. It is available from five suppliers. Additional details are available on the CLOMIPHENE CITRATE profile page.

The generic ingredient in CLOMIPHENE CITRATE is clomiphene citrate. There are fifteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the clomiphene citrate profile page.
Summary for 075528
Applicant:Par Pharm
Ingredient:clomiphene citrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 075528
Medical Subject Heading (MeSH) Categories for 075528
Suppliers and Packaging for NDA: 075528
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOMIPHENE CITRATE clomiphene citrate TABLET;ORAL 075528 ANDA Rebel Distributors Corp 21695-114 21695-114-10 1 BLISTER PACK in 1 CARTON (21695-114-10) > 10 TABLET in 1 BLISTER PACK
CLOMIPHENE CITRATE clomiphene citrate TABLET;ORAL 075528 ANDA Par Pharmaceutical, Inc. 49884-701 49884-701-54 1 BLISTER PACK in 1 CARTON (49884-701-54) > 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Aug 30, 1999TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
Argus Health
Federal Trade Commission

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