Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217263
Company: AM REGENT
Company: AM REGENT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXTROSE 5% | DEXTROSE | 50MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
04/08/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
DEXTROSE 5%
INJECTABLE;INJECTION; 50MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXTROSE 5% | DEXTROSE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217263 | AM REGENT |
DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 50MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 016730 | B BRAUN |
DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 50MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 016673 | BAXTER HLTHCARE |
DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 50MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020179 | BAXTER HLTHCARE |
DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207449 | FRESENIUS KABI USA |
DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 50MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 016367 | ICU MEDICAL INC |