Details for New Drug Application (NDA): 219406
NDA 219406 describes CLOMIPHENE CITRATE, which is a drug marketed by Accord Hlthcare, Appco, Ascent Pharms Inc, Novitium Pharma, and Rubicon Research, and is included in five NDAs. It is available from seven suppliers. Additional details are available on the CLOMIPHENE CITRATE profile page.
The generic ingredient in CLOMIPHENE CITRATE 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 CLOMIPHENE CITRATE 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 219406
| Tradename: | CLOMIPHENE CITRATE |
| Applicant: | Accord Hlthcare |
| Ingredient: | clomiphene citrate |
| Patents: | 0 |
Pharmacology for NDA: 219406
| Mechanism of Action | Selective Estrogen Receptor Modulators |
Medical Subject Heading (MeSH) Categories for 219406
Suppliers and Packaging for NDA: 219406
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOMIPHENE CITRATE | clomiphene citrate | TABLET;ORAL | 219406 | ANDA | Accord Healthcare Inc. | 16729-723 | 16729-723-51 | 1 BLISTER PACK in 1 CARTON (16729-723-51) / 30 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Oct 3, 2025 | TE: | AB | RLD: | No | ||||
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