Details for New Drug Application (NDA): 065409
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NDA 065409 describes CEFPODOXIME PROXETIL, which is a drug marketed by Aurobindo Pharma Ltd, Sandoz, Sun Pharm Inds Ltd, Alkem Labs Ltd, Anda Repository, and Aurobindo Pharma, 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 065409
| Tradename: | CEFPODOXIME PROXETIL |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | cefpodoxime proxetil |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065409
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFPODOXIME PROXETIL | cefpodoxime proxetil | FOR SUSPENSION;ORAL | 065409 | ANDA | NorthStar Rx LLC | 16714-402 | 16714-402-01 | 1 BOTTLE in 1 CARTON (16714-402-01) / 50 mL in 1 BOTTLE |
| CEFPODOXIME PROXETIL | cefpodoxime proxetil | FOR SUSPENSION;ORAL | 065409 | ANDA | NorthStar Rx LLC | 16714-402 | 16714-402-02 | 1 BOTTLE in 1 CARTON (16714-402-02) / 100 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 50MG BASE/5ML | ||||
| Approval Date: | Jun 8, 2007 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 100MG BASE/5ML | ||||
| Approval Date: | Jun 8, 2007 | TE: | RLD: | No | |||||
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