Application 065047
- Type
- ANDA
- Sponsor
- HIKMA FARMACEUTICA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | Yes |
| 002 | CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0143-9262 | Cefazolin | Cefazolin | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9262 | Cefazolin | Cefazolin | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9923 | Cefazolin | Cefazolin | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9923 | Cefazolin | Cefazolin | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9924 | Cefazolin | Cefazolin | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9924 | Cefazolin | Cefazolin | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0404-9834 | CEFAZOLIN | cefazolin | Henry Schein, Inc. | ANDA | Current |
| 0404-9834 | CEFAZOLIN | cefazolin | Henry Schein, Inc. | ANDA | Current |
| 0404-9834 | CEFAZOLIN | cefazolin | Henry Schein, Inc. | ANDA | Current |
| 0404-9834 | CEFAZOLIN | cefazolin | Henry Schein, Inc. | ANDA | Current |
| 0404-9835 | CEFAZOLIN | cefazolin | Henry Schein Inc. | ANDA | Current |
| 0404-9835 | CEFAZOLIN | cefazolin | Henry Schein Inc. | ANDA | Current |
| 0404-9835 | CEFAZOLIN | cefazolin | Henry Schein Inc. | ANDA | Current |
| 50090-4256 | Cefazolin | Cefazolin | A-S Medication Solutions | ANDA | Current |
| 52584-923 | CEFAZOLIN | cefazolin | General Injectables & Vaccines, Inc. | ANDA | Current |
| 52584-923 | CEFAZOLIN | cefazolin | General Injectables & Vaccines, Inc. | ANDA | Current |
| 52584-923 | CEFAZOLIN | cefazolin | General Injectables & Vaccines, Inc. | ANDA | Current |
| 52584-924 | CEFAZOLIN | cefazolin | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-924 | CEFAZOLIN | cefazolin | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-924 | CEFAZOLIN | cefazolin | General Injectables and Vaccines, Inc. | ANDA | Current |
| 55154-7463 | Cefazolin | Cefazolin | Cardinal Health | ANDA | Current |
| 71872-7027 | Cefazolin | Cefazolin | Medical Purchasing Solutions, LLC | ANDA | Current |
| 71872-7027 | Cefazolin | Cefazolin | Medical Purchasing Solutions, LLC | ANDA | Current |
| 72572-055 | Cefazolin | Cefazolin | Civica, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 22306 | ORIG | 2004-12-08 |
| 30635 | ORIG | 2003-04-10 |