Details for New Drug Application (NDA): 204309
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NDA 204309 describes PHENYTOIN SODIUM, which is a drug marketed by Aurobindo Pharma, Pharmeral, Watson Labs, Acella, Am Regent, Fresenius Kabi Usa, Hikma, Hospira, Marsam Pharms Llc, Smith And Nephew, Solopak, and Warner Chilcott, and is included in sixteen NDAs. It is available from eleven suppliers. Additional details are available on the PHENYTOIN SODIUM profile page.
The generic ingredient in PHENYTOIN SODIUM is phenytoin sodium. There are twenty-one drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.
The generic ingredient in PHENYTOIN SODIUM is phenytoin sodium. There are twenty-one drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.
Summary for 204309
| Tradename: | PHENYTOIN SODIUM |
| Applicant: | Aurobindo Pharma |
| Ingredient: | phenytoin sodium |
| Patents: | 0 |
Pharmacology for NDA: 204309
Suppliers and Packaging for NDA: 204309
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PHENYTOIN SODIUM | phenytoin sodium | CAPSULE;ORAL | 204309 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8556 | 0615-8556-39 | 30 CAPSULE in 1 BLISTER PACK (0615-8556-39) |
| PHENYTOIN SODIUM | phenytoin sodium | CAPSULE;ORAL | 204309 | ANDA | American Health Packaging | 60687-841 | 60687-841-01 | 100 BLISTER PACK in 1 CARTON (60687-841-01) / 1 CAPSULE in 1 BLISTER PACK (60687-841-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG EXTENDED | ||||
| Approval Date: | Jun 10, 2015 | TE: | AB | RLD: | No | ||||
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