Details for New Drug Application (NDA): 075528
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NDA 075528 describes CLOMIPHENE CITRATE, which is a drug marketed by Cosette 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 sixteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the clomiphene citrate profile page.
The generic ingredient in CLOMIPHENE CITRATE is clomiphene citrate. There are sixteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the clomiphene citrate profile page.
Summary for 075528
| Tradename: | CLOMIPHENE CITRATE |
| Applicant: | Cosette |
| Ingredient: | clomiphene citrate |
| Patents: | 0 |
Pharmacology for NDA: 075528
| Mechanism of Action | Selective Estrogen Receptor Modulators |
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 | Cosette Pharmaceuticals, Inc. | 0713-0885 | 0713-0885-09 | 1 BLISTER PACK in 1 CARTON (0713-0885-09) / 10 TABLET in 1 BLISTER PACK |
| CLOMIPHENE CITRATE | clomiphene citrate | TABLET;ORAL | 075528 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0885 | 0713-0885-30 | 3 BLISTER PACK in 1 CARTON (0713-0885-30) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Aug 30, 1999 | TE: | RLD: | No | |||||
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