Details for New Drug Application (NDA): 065392
✉ Email this page to a colleague
NDA 065392 describes CEFADROXIL, which is a drug marketed by Aurobindo Pharma, Chartwell Rx, Cspc Ouyi, Hikma, Ivax Sub Teva Pharms, Lupin, Purepac Pharm, Ranbaxy Labs Ltd, Sandoz, Teva, Teva Pharms, Ani Pharms, Apothecon, Aurobindo, Hikma Pharms, Sun Pharm Inds Ltd, and Ranbaxy, and is included in twenty-three NDAs. It is available from twenty-two suppliers. Additional details are available on the CEFADROXIL profile page.
The generic ingredient in CEFADROXIL is cefadroxil/cefadroxil hemihydrate. Twenty-two suppliers are listed for this compound. Additional details are available on the cefadroxil/cefadroxil hemihydrate profile page.
The generic ingredient in CEFADROXIL is cefadroxil/cefadroxil hemihydrate. Twenty-two suppliers are listed for this compound. Additional details are available on the cefadroxil/cefadroxil hemihydrate profile page.
Summary for 065392
| Tradename: | CEFADROXIL |
| Applicant: | Lupin |
| Ingredient: | cefadroxil/cefadroxil hemihydrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065392
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFADROXIL | cefadroxil/cefadroxil hemihydrate | CAPSULE;ORAL | 065392 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-553 | 43063-553-10 | 10 CAPSULE in 1 BOTTLE, PLASTIC (43063-553-10) |
| CEFADROXIL | cefadroxil/cefadroxil hemihydrate | CAPSULE;ORAL | 065392 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-553 | 43063-553-14 | 14 CAPSULE in 1 BOTTLE, PLASTIC (43063-553-14) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | May 29, 2007 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
