Product NDC: | 49349-495 |
Proprietary Name: | Dilantin |
Non Proprietary Name: | PHENYTOIN |
Active Ingredient(s): | 50 mg/1 & nbsp; PHENYTOIN |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, CHEWABLE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 49349-495 |
Labeler Name: | REMEDYREPACK INC. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA084427 |
Marketing Category: | ANDA |
Start Marketing Date: | 20110818 |
Package NDC: | 49349-495-02 |
Package Description: | 30 TABLET, CHEWABLE in 1 BLISTER PACK (49349-495-02) |
NDC Code | 49349-495-02 |
Proprietary Name | Dilantin |
Package Description | 30 TABLET, CHEWABLE in 1 BLISTER PACK (49349-495-02) |
Product NDC | 49349-495 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | PHENYTOIN |
Dosage Form Name | TABLET, CHEWABLE |
Route Name | ORAL |
Start Marketing Date | 20110818 |
Marketing Category Name | ANDA |
Labeler Name | REMEDYREPACK INC. |
Substance Name | PHENYTOIN |
Strength Number | 50 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |