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Application 065441
- Type
- ANDA
- Sponsor
- ACS DOBFAR
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CEFEPIME HYDROCHLORIDE | CEFEPIME HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
| 002 | CEFEPIME HYDROCHLORIDE | CEFEPIME HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0409-9566 | Cefepime | Cefepime | Hospira, Inc. | ANDA | Current |
| 0409-9566 | Cefepime | Cefepime | Hospira, Inc. | ANDA | Current |
| 0409-9735 | Cefepime | Cefepime | Hospira, Inc. | ANDA | Current |
| 0409-9735 | Cefepime | Cefepime | Hospira, Inc. | ANDA | Current |
| 0781-3222 | Cefepime Hydrochloride | Cefepime Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-3223 | Cefepime Hydrochloride | Cefepime Hydrochloride | Sandoz Inc | ANDA | Current |
| 25021-121 | cefepime | cefepime hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 25021-121 | cefepime | cefepime hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 25021-121 | cefepime | cefepime hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 25021-121 | cefepime | cefepime hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 25021-121 | cefepime | cefepime hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 25021-121 | cefepime | cefepime hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 25021-121 | cefepime | cefepime hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 25021-121 | cefepime | cefepime hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 25021-122 | cefepime | cefepime hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 25021-122 | cefepime | cefepime hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 25021-122 | cefepime | cefepime hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 25021-122 | cefepime | cefepime hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 25021-122 | cefepime | cefepime hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 25021-122 | cefepime | cefepime hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 25021-122 | cefepime | cefepime hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 25021-122 | cefepime | cefepime hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 44567-130 | Cefepime | Cefepime | WG Critical Care, LLC | ANDA | Current |
| 44567-130 | Cefepime | Cefepime | WG Critical Care, LLC | ANDA | Current |
| 44567-131 | Cefepime | Cefepime | WG Critical Care, LLC | ANDA | Current |
| 44567-131 | Cefepime | Cefepime | WG Critical Care, LLC | ANDA | Current |
| 44567-240 | Cefepime | Cefepime | WG Critical Care, LLC | ANDA | Current |
| 44567-240 | Cefepime | Cefepime | WG Critical Care, LLC | ANDA | Current |
| 44567-240 | Cefepime | Cefepime | WG Critical Care, LLC | ANDA | Current |
| 44567-240 | Cefepime | Cefepime | WG Critical Care, LLC | ANDA | Current |
| 44567-240 | Cefepime | Cefepime | WG Critical Care, LLC | ANDA | Current |
| 44567-240 | Cefepime | Cefepime | WG Critical Care, LLC | ANDA | Current |
| 44567-241 | Cefepime | Cefepime | WG Critical Care, LLC | ANDA | Current |
| 44567-241 | Cefepime | Cefepime | WG Critical Care, LLC | ANDA | Current |
| 44567-241 | Cefepime | Cefepime | WG Critical Care, LLC | ANDA | Current |
| 44567-241 | Cefepime | Cefepime | WG Critical Care, LLC | ANDA | Current |
| 44567-241 | Cefepime | Cefepime | WG Critical Care, LLC | ANDA | Current |
| 44567-241 | Cefepime | Cefepime | WG Critical Care, LLC | ANDA | Current |
| 63323-326 | Cefepime | Cefepime | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-340 | Cefepime | Cefepime | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44240 | ORIG | 2008-03-21 |