Details for New Drug Application (NDA): 216600
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NDA 216600 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 216600
| Tradename: | FOSFOMYCIN TROMETHAMINE |
| Applicant: | Amneal |
| Ingredient: | fosfomycin tromethamine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 216600
Suppliers and Packaging for NDA: 216600
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FOSFOMYCIN TROMETHAMINE | fosfomycin tromethamine | FOR SOLUTION;ORAL | 216600 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-3955 | 60219-3955-1 | 1 PACKET in 1 CARTON (60219-3955-1) / 1 GRANULE, FOR SOLUTION in 1 PACKET (60219-3955-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 3GM BASE/PACKET | ||||
| Approval Date: | Mar 25, 2024 | TE: | AA | RLD: | No | ||||
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