Details for New Drug Application (NDA): 065308
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NDA 065308 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 seventeen suppliers. Additional details are available on the CEFUROXIME AXETIL profile page.
The generic ingredient in CEFUROXIME AXETIL is cefuroxime axetil. There is one drug master file entry for this compound. Seventeen 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 is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the cefuroxime axetil profile page.
Summary for 065308
| Tradename: | CEFUROXIME AXETIL |
| Applicant: | Aurobindo Pharma |
| Ingredient: | cefuroxime axetil |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065308
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFUROXIME AXETIL | cefuroxime axetil | TABLET;ORAL | 065308 | ANDA | NorthStar Rx LLC | 16714-400 | 16714-400-01 | 20 TABLET in 1 BOTTLE (16714-400-01) |
| CEFUROXIME AXETIL | cefuroxime axetil | TABLET;ORAL | 065308 | ANDA | NorthStar Rx LLC | 16714-400 | 16714-400-02 | 60 TABLET in 1 BOTTLE (16714-400-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 125MG BASE | ||||
| Approval Date: | Mar 29, 2006 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Mar 29, 2006 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Mar 29, 2006 | TE: | AB | RLD: | No | ||||
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