Details for New Drug Application (NDA): 212271
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NDA 212271 describes CONTEPO, which is a drug marketed by Meitheal and is included in one NDA. It is available from one supplier. Additional details are available on the CONTEPO profile page.
The generic ingredient in CONTEPO is fosfomycin disodium. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fosfomycin disodium profile page.
The generic ingredient in CONTEPO is fosfomycin disodium. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fosfomycin disodium profile page.
Summary for 212271
| Tradename: | CONTEPO |
| Applicant: | Meitheal |
| Ingredient: | fosfomycin disodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212271
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CONTEPO | fosfomycin disodium | POWDER;INTRAVENOUS | 212271 | NDA | Meitheal Pharmaceuticals Inc. | 71288-035 | 71288-035-52 | 12 VIAL, GLASS in 1 CARTON (71288-035-52) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (71288-035-51) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 6GM BASE/VIAL | ||||
| Approval Date: | Oct 22, 2025 | TE: | RLD: | Yes | |||||
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