Details for New Drug Application (NDA): 206694
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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 206694
Tradename: | TAMOXIFEN CITRATE |
Applicant: | Zydus Pharms |
Ingredient: | tamoxifen citrate |
Patents: | 0 |
Pharmacology for NDA: 206694
Mechanism of Action | Selective Estrogen Receptor Modulators |
Medical Subject Heading (MeSH) Categories for 206694
Suppliers and Packaging for NDA: 206694
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TAMOXIFEN CITRATE | tamoxifen citrate | TABLET;ORAL | 206694 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-826 | 68382-826-01 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-826-01) |
TAMOXIFEN CITRATE | tamoxifen citrate | TABLET;ORAL | 206694 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-826 | 68382-826-14 | 60 TABLET, FILM COATED in 1 BOTTLE (68382-826-14) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Oct 27, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Oct 27, 2017 | TE: | AB | RLD: | No |
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