Details for New Drug Application (NDA): 212818
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NDA 212818 describes TOREMIFENE CITRATE, which is a drug marketed by MSN and Rising and is included in two NDAs. It is available from three 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. Four 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. Four suppliers are listed for this compound. Additional details are available on the toremifene citrate profile page.
Summary for 212818
| Tradename: | TOREMIFENE CITRATE |
| Applicant: | Msn |
| Ingredient: | toremifene citrate |
| Patents: | 0 |
Pharmacology for NDA: 212818
| Mechanism of Action | Selective Estrogen Receptor Modulators |
Medical Subject Heading (MeSH) Categories for 212818
Suppliers and Packaging for NDA: 212818
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOREMIFENE CITRATE | toremifene citrate | TABLET;ORAL | 212818 | ANDA | MSN LABORATORIES PRIVATE LIMITED | 69539-152 | 69539-152-30 | 30 TABLET in 1 BOTTLE (69539-152-30) |
| TOREMIFENE CITRATE | toremifene citrate | TABLET;ORAL | 212818 | ANDA | Novadoz Pharmaceuticals LLC | 72205-050 | 72205-050-30 | 30 TABLET in 1 BOTTLE (72205-050-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 60MG BASE | ||||
| Approval Date: | Aug 18, 2020 | TE: | AB | RLD: | No | ||||
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