Details for New Drug Application (NDA): 203704
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NDA 203704 describes CEFEPIME HYDROCHLORIDE, which is a drug marketed by Acs Dobfar, Astral, Chartwell Rx, Hikma, Hospira Inc, Qilu Antibiotics, Sagent Pharms Inc, and Samson Medcl, and is included in nine NDAs. It is available from eight suppliers. Additional details are available on the CEFEPIME HYDROCHLORIDE profile page.
The generic ingredient in CEFEPIME HYDROCHLORIDE is cefepime hydrochloride. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the cefepime hydrochloride profile page.
The generic ingredient in CEFEPIME HYDROCHLORIDE is cefepime hydrochloride. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the cefepime hydrochloride profile page.
Summary for 203704
| Tradename: | CEFEPIME HYDROCHLORIDE |
| Applicant: | Qilu Antibiotics |
| Ingredient: | cefepime hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203704
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFEPIME HYDROCHLORIDE | cefepime hydrochloride | INJECTABLE;INJECTION | 203704 | ANDA | Apotex Corp. | 60505-6144 | 60505-6144-4 | 10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6144-4) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| CEFEPIME HYDROCHLORIDE | cefepime hydrochloride | INJECTABLE;INJECTION | 203704 | ANDA | Apotex Corp. | 60505-6145 | 60505-6145-4 | 10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6145-4) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Feb 1, 2016 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Feb 1, 2016 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL | ||||
| Approval Date: | Feb 1, 2016 | TE: | AP | RLD: | No | ||||
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