Details for New Drug Application (NDA): 208813
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NDA 208813 describes TOREMIFENE CITRATE, which is a drug marketed by MSN and Rising and is included in two NDAs. It is available from two suppliers. Additional details are available on the TOREMIFENE CITRATE profile page.
The generic ingredient in TOREMIFENE CITRATE is toremifene citrate. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the toremifene citrate profile page.
The generic ingredient in TOREMIFENE CITRATE is toremifene citrate. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the toremifene citrate profile page.
Summary for 208813
| Tradename: | TOREMIFENE CITRATE |
| Applicant: | Rising |
| Ingredient: | toremifene citrate |
| Patents: | 0 |
Pharmacology for NDA: 208813
| Mechanism of Action | Selective Estrogen Receptor Modulators |
Medical Subject Heading (MeSH) Categories for 208813
Suppliers and Packaging for NDA: 208813
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOREMIFENE CITRATE | toremifene citrate | TABLET;ORAL | 208813 | ANDA | Rising Pharma Holdings, Inc. | 64980-404 | 64980-404-03 | 30 TABLET in 1 BOTTLE, PLASTIC (64980-404-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 60MG BASE | ||||
| Approval Date: | Dec 4, 2018 | TE: | AB | RLD: | No | ||||
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