Details for New Drug Application (NDA): 075528
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NDA 075528 describes CLOMID, which is a drug marketed by Cosette and Sanofi Aventis Us and is included in two NDAs. It is available from three suppliers. Additional details are available on the CLOMID profile page.
The generic ingredient in CLOMID is clomiphene citrate. There is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the clomiphene citrate profile page.
The generic ingredient in CLOMID is clomiphene citrate. There is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the clomiphene citrate profile page.
Summary for 075528
| Tradename: | CLOMID |
| 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 |
|---|---|---|---|---|---|---|---|---|
| CLOMID | 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 |
| CLOMID | 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: | AB | RLD: | No | ||||
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