Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214554
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FOSFOMYCIN TROMETHAMINE | FOSFOMYCIN TROMETHAMINE | EQ 3GM BASE/PACKET | FOR SOLUTION;ORAL | Prescription | AA | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/21/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
FOSFOMYCIN TROMETHAMINE
FOR SOLUTION;ORAL; EQ 3GM BASE/PACKET
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FOSFOMYCIN TROMETHAMINE | FOSFOMYCIN TROMETHAMINE | EQ 3GM BASE/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 214554 | ALKEM LABS LTD |
FOSFOMYCIN TROMETHAMINE | FOSFOMYCIN TROMETHAMINE | EQ 3GM BASE/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 216600 | AMNEAL |
FOSFOMYCIN TROMETHAMINE | FOSFOMYCIN TROMETHAMINE | EQ 3GM BASE/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 211881 | CIPLA |
FOSFOMYCIN TROMETHAMINE | FOSFOMYCIN TROMETHAMINE | EQ 3GM BASE/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 212548 | XIROMED |
MONUROL | FOSFOMYCIN TROMETHAMINE | EQ 3GM BASE/PACKET | FOR SOLUTION;ORAL | Prescription | Yes | AA | 050717 | ZAMBON SPA |