Details for New Drug Application (NDA): 200565
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The generic ingredient in PHENYTOIN is phenytoin sodium. There are twenty-one drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.
Summary for 200565
Tradename: | PHENYTOIN |
Applicant: | Taro |
Ingredient: | phenytoin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 200565
Medical Subject Heading (MeSH) Categories for 200565
Suppliers and Packaging for NDA: 200565
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PHENYTOIN | phenytoin | TABLET, CHEWABLE;ORAL | 200565 | ANDA | Major Pharmaceuticals | 0904-7199 | 0904-7199-07 | 30 BLISTER PACK in 1 CARTON (0904-7199-07) / 1 TABLET, CHEWABLE in 1 BLISTER PACK |
PHENYTOIN | phenytoin | TABLET, CHEWABLE;ORAL | 200565 | ANDA | Taro Pharmaceuticals U.S.A., Inc | 51672-4146 | 51672-4146-1 | 100 TABLET, CHEWABLE in 1 BOTTLE (51672-4146-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 50MG | ||||
Approval Date: | Apr 17, 2014 | TE: | AB | RLD: | No |
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