Details for New Drug Application (NDA): 072196
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NDA 072196 describes MILOPHENE, which is a drug marketed by Granata Bio Corp and is included in one NDA. It is available from one supplier. Additional details are available on the MILOPHENE profile page.
The generic ingredient in MILOPHENE 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 MILOPHENE 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 072196
| Tradename: | MILOPHENE |
| Applicant: | Granata Bio Corp |
| Ingredient: | clomiphene citrate |
| Patents: | 0 |
Pharmacology for NDA: 072196
| Mechanism of Action | Selective Estrogen Receptor Modulators |
Medical Subject Heading (MeSH) Categories for 072196
Suppliers and Packaging for NDA: 072196
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MILOPHENE | clomiphene citrate | TABLET;ORAL | 072196 | ANDA | Burel Pharmaceuticals, LLC | 35573-470 | 35573-470-30 | 30 TABLET in 1 BOTTLE (35573-470-30) |
| MILOPHENE | clomiphene citrate | TABLET;ORAL | 072196 | ANDA | Burel Pharmaceuticals, LLC | 35573-470 | 35573-470-75 | 10 TABLET in 1 BOTTLE (35573-470-75) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Dec 20, 1988 | TE: | AB | RLD: | No | ||||
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