Details for New Drug Application (NDA): 213358
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NDA 213358 describes TAMOXIFEN CITRATE, which is a drug marketed by Actavis Labs Fl Inc, Aegis Pharms, Apotex, Dr Reddys Labs Sa, Eugia Pharma, Ivax Sub Teva Pharms, Mylan, Pharmachemie, Roxane, Teva, and Zydus Pharms, and is included in twelve NDAs. It is available from thirteen suppliers. Additional details are available on the TAMOXIFEN CITRATE profile page.
The generic ingredient in TAMOXIFEN CITRATE is tamoxifen citrate. There are sixteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the tamoxifen citrate profile page.
The generic ingredient in TAMOXIFEN CITRATE is tamoxifen citrate. There are sixteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the tamoxifen citrate profile page.
Summary for 213358
| Tradename: | TAMOXIFEN CITRATE |
| Applicant: | Eugia Pharma |
| Ingredient: | tamoxifen citrate |
| Patents: | 0 |
Pharmacology for NDA: 213358
| Mechanism of Action | Selective Estrogen Receptor Modulators |
Medical Subject Heading (MeSH) Categories for 213358
Suppliers and Packaging for NDA: 213358
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TAMOXIFEN CITRATE | tamoxifen citrate | TABLET;ORAL | 213358 | ANDA | Aurobindo Pharma Limited | 59651-299 | 59651-299-60 | 60 TABLET, FILM COATED in 1 BOTTLE (59651-299-60) |
| TAMOXIFEN CITRATE | tamoxifen citrate | TABLET;ORAL | 213358 | ANDA | Aurobindo Pharma Limited | 59651-300 | 59651-300-30 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-300-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Aug 14, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Aug 14, 2020 | TE: | AB | RLD: | No | ||||
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