Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202605
Company: CUSTOPHARM INC
Company: CUSTOPHARM INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN | ACETAMINOPHEN | 1GM/100ML (10MG/ML) | SOLUTION;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 06/13/2016 | ORIG-1 | Approval |
Label is not available on this site. |
ACETAMINOPHEN
SOLUTION;INTRAVENOUS; 1GM/100ML (10MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN | ACETAMINOPHEN | 1GM/100ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 210969 | AUROBINDO PHARMA LTD |
| ACETAMINOPHEN | ACETAMINOPHEN | 1GM/100ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 202605 | CUSTOPHARM INC |
| ACETAMINOPHEN | ACETAMINOPHEN | 1GM/100ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213255 | MYLAN |
| ACETAMINOPHEN | ACETAMINOPHEN | 1GM/100ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 204052 | SANDOZ INC |
| OFIRMEV | ACETAMINOPHEN | 1GM/100ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 022450 | MALLINCKRODT HOSP |
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