Details for New Drug Application (NDA): 219781
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NDA 219781 describes CLOMIPHENE CITRATE, which is a drug marketed by Accord Hlthcare, Appco, Cosette, Novitium Pharma, and Rubicon, and is included in five NDAs. It is available from eight 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. Nine 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. Nine suppliers are listed for this compound. Additional details are available on the clomiphene citrate profile page.
Summary for 219781
| Tradename: | CLOMIPHENE CITRATE |
| Applicant: | Novitium Pharma |
| Ingredient: | clomiphene citrate |
| Patents: | 0 |
Pharmacology for NDA: 219781
| Mechanism of Action | Selective Estrogen Receptor Modulators |
Medical Subject Heading (MeSH) Categories for 219781
Suppliers and Packaging for NDA: 219781
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOMIPHENE CITRATE | clomiphene citrate | TABLET;ORAL | 219781 | ANDA | ANI Pharmaceuticals, Inc. | 70954-825 | 70954-825-20 | 10 BLISTER PACK in 1 CARTON (70954-825-20) / 1 TABLET in 1 BLISTER PACK (70954-825-10) |
| CLOMIPHENE CITRATE | clomiphene citrate | TABLET;ORAL | 219781 | ANDA | ANI Pharmaceuticals, Inc. | 70954-825 | 70954-825-30 | 30 BLISTER PACK in 1 CARTON (70954-825-30) / 1 TABLET in 1 BLISTER PACK (70954-825-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Oct 17, 2025 | TE: | AB | RLD: | No | ||||
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