Details for New Drug Application (NDA): 050588
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NDA 050588 describes CEFOTAN, which is a drug marketed by Pai Holdings Pharm and Teligent and is included in three NDAs. It is available from one supplier. Additional details are available on the CEFOTAN profile page.
The generic ingredient in CEFOTAN is cefotetan disodium. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cefotetan disodium profile page.
The generic ingredient in CEFOTAN is cefotetan disodium. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cefotetan disodium profile page.
Summary for 050588
| Tradename: | CEFOTAN |
| Applicant: | Pai Holdings Pharm |
| Ingredient: | cefotetan disodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 050588
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFOTAN | cefotetan disodium | INJECTABLE;INJECTION | 050588 | NDA | PAI Holdings, LLC dba PAI Pharma | 0121-0976 | 0121-0976-10 | 10 VIAL in 1 TRAY (0121-0976-10) / 10 mL in 1 VIAL (0121-0976-55) |
| CEFOTAN | cefotetan disodium | INJECTABLE;INJECTION | 050588 | NDA | PAI Holdings, LLC dba PAI Pharma | 0121-0977 | 0121-0977-10 | 10 VIAL in 1 TRAY (0121-0977-10) / 20 mL in 1 VIAL (0121-0977-55) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 27, 1985 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 27, 1985 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10GM BASE/VIAL | ||||
| Approval Date: | Apr 25, 1988 | TE: | RLD: | No | |||||
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