Details for New Drug Application (NDA): 065370
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NDA 065370 describes CEFPODOXIME PROXETIL, which is a drug marketed by Aurobindo Pharma Ltd, Chartwell Rx, Sun Pharm Inds Ltd, Alkem Labs Ltd, Anda Repository, Aurobindo Pharma, and Sandoz, and is included in eight NDAs. It is available from ten suppliers. Additional details are available on the CEFPODOXIME PROXETIL profile page.
The generic ingredient in CEFPODOXIME PROXETIL is cefpodoxime proxetil. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cefpodoxime proxetil profile page.
The generic ingredient in CEFPODOXIME PROXETIL is cefpodoxime proxetil. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cefpodoxime proxetil profile page.
Summary for 065370
| Tradename: | CEFPODOXIME PROXETIL |
| Applicant: | Aurobindo Pharma |
| Ingredient: | cefpodoxime proxetil |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065370
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFPODOXIME PROXETIL | cefpodoxime proxetil | TABLET;ORAL | 065370 | ANDA | NorthStar Rx LLC | 16714-394 | 16714-394-01 | 20 TABLET, FILM COATED in 1 BOTTLE (16714-394-01) |
| CEFPODOXIME PROXETIL | cefpodoxime proxetil | TABLET;ORAL | 065370 | ANDA | NorthStar Rx LLC | 16714-395 | 16714-395-01 | 20 TABLET, FILM COATED in 1 BOTTLE (16714-395-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Jun 11, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Jun 11, 2007 | TE: | AB | RLD: | No | ||||
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