Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217341
Company: AM REGENT
Company: AM REGENT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (10ML) | LIQUID;N/A | Prescription | AP | No | No |
STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (20ML) | LIQUID;N/A | Prescription | AP | No | No |
STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (5ML) | LIQUID;N/A | 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 |
---|---|---|---|---|---|---|---|
08/29/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/09/2024 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
STERILE WATER FOR INJECTION
LIQUID;N/A; 100% (10ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (10ML) | LIQUID;N/A | Prescription | No | AP | 217341 | AM REGENT |
STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (10ML) | LIQUID;N/A | Prescription | No | AP | 206369 | HIKMA |
STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (10ML) | LIQUID;N/A | Prescription | Yes | AP | 018801 | HOSPIRA |
STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (10ML) | LIQUID;N/A | Prescription | No | AP | 211188 | MEDEFIL INC |
STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (10ML) | LIQUID;N/A | Prescription | No | AP | 217536 | NEXUS |
LIQUID;N/A; 100% (20ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (20ML) | LIQUID;N/A | Prescription | No | AP | 217341 | AM REGENT |
STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (20ML) | LIQUID;N/A | Prescription | Yes | AP | 018801 | HOSPIRA |
STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (20ML) | LIQUID;N/A | Prescription | No | AP | 217536 | NEXUS |
LIQUID;N/A; 100% (5ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (5ML) | LIQUID;N/A | Prescription | No | AP | 217341 | AM REGENT |
STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (5ML) | LIQUID;N/A | Prescription | No | AP | 211188 | MEDEFIL INC |
STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (5ML) | LIQUID;N/A | Prescription | No | AP | 211222 | NEPHRON |