Details for New Drug Application (NDA): 209408
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NDA 209408 describes CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER, which is a drug marketed by Samson Medcl and is included in one NDA. It is available from one supplier. Additional details are available on the CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER profile page.
The generic ingredient in CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER is cefepime hydrochloride. There are twenty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the cefepime hydrochloride profile page.
The generic ingredient in CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER is cefepime hydrochloride. There are twenty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the cefepime hydrochloride profile page.
Summary for 209408
| Tradename: | CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER |
| Applicant: | Samson Medcl |
| Ingredient: | cefepime hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209408
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER | cefepime hydrochloride | POWDER;INTRAVENOUS | 209408 | ANDA | SAMSON MEDICAL TECHNOLOGIES LLC | 66288-8100 | 66288-8100-1 | 1 BAG in 1 BAG (66288-8100-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 100GM BASE | ||||
| Approval Date: | Aug 21, 2018 | TE: | RLD: | No | |||||
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