Details for New Drug Application (NDA): 065496
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NDA 065496 describes CEFUROXIME AXETIL, which is a drug marketed by Sun Pharm Inds Ltd, Alkem Labs Ltd, Anda Repository, Ani Pharms, Apotex, Aurobindo Pharma, Chartwell Rx, Fosun Pharma, Lupin, and Ranbaxy Labs Ltd, and is included in eleven NDAs. It is available from fifteen suppliers. Additional details are available on the CEFUROXIME AXETIL profile page.
The generic ingredient in CEFUROXIME AXETIL is cefuroxime axetil. There are sixty-two drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the cefuroxime axetil profile page.
The generic ingredient in CEFUROXIME AXETIL is cefuroxime axetil. There are sixty-two drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the cefuroxime axetil profile page.
Summary for 065496
| Tradename: | CEFUROXIME AXETIL |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | cefuroxime axetil |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065496
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFUROXIME AXETIL | cefuroxime axetil | TABLET;ORAL | 065496 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-656 | 43063-656-14 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-656-14) |
| CEFUROXIME AXETIL | cefuroxime axetil | TABLET;ORAL | 065496 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-656 | 43063-656-20 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-656-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Jun 7, 2010 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Jun 7, 2010 | TE: | AB | RLD: | No | ||||
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