Details for New Drug Application (NDA): 214554
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NDA 214554 describes FOSFOMYCIN TROMETHAMINE, which is a drug marketed by Alkem Labs Ltd, Amneal, Cipla, and Xiromed, and is included in four NDAs. It is available from five suppliers. Additional details are available on the FOSFOMYCIN TROMETHAMINE profile page.
The generic ingredient in FOSFOMYCIN TROMETHAMINE is fosfomycin tromethamine. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fosfomycin tromethamine profile page.
The generic ingredient in FOSFOMYCIN TROMETHAMINE is fosfomycin tromethamine. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fosfomycin tromethamine profile page.
Summary for 214554
| Tradename: | FOSFOMYCIN TROMETHAMINE |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | fosfomycin tromethamine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 214554
Suppliers and Packaging for NDA: 214554
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FOSFOMYCIN TROMETHAMINE | fosfomycin tromethamine | FOR SOLUTION;ORAL | 214554 | ANDA | A-S Medication Solutions | 50090-6130 | 50090-6130-0 | 1 PACKET in 1 CARTON (50090-6130-0) / 1 GRANULE, FOR SOLUTION in 1 PACKET |
| FOSFOMYCIN TROMETHAMINE | fosfomycin tromethamine | FOR SOLUTION;ORAL | 214554 | ANDA | Ascend Laboratories, LLC | 67877-749 | 67877-749-57 | 1 PACKET in 1 CARTON (67877-749-57) / 1 GRANULE, FOR SOLUTION in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 3GM BASE/PACKET | ||||
| Approval Date: | Oct 21, 2021 | TE: | AA | RLD: | No | ||||
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