Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209937
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM TETRADECYL SULFATE | SODIUM TETRADECYL SULFATE | 60MG/2ML (30MG/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 |
---|---|---|---|---|---|---|---|
12/09/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
SODIUM TETRADECYL SULFATE
INJECTABLE;INJECTION; 60MG/2ML (30MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SODIUM TETRADECYL SULFATE | SODIUM TETRADECYL SULFATE | 60MG/2ML (30MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 209937 | HIKMA |
SOTRADECOL | SODIUM TETRADECYL SULFATE | 60MG/2ML (30MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040541 | MYLAN INSTITUTIONAL |