Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040607
Company: SAPTALIS PHARMS
Company: SAPTALIS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETIC ACID | ACETIC ACID, GLACIAL | 2% | SOLUTION/DROPS;OTIC | Prescription | AT | 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 |
|---|---|---|---|---|---|---|---|
| 02/24/2005 | ORIG-1 | Approval |
Label is not available on this site. |
ACETIC ACID
SOLUTION/DROPS;OTIC; 2%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETIC ACID | ACETIC ACID, GLACIAL | 2% | SOLUTION/DROPS;OTIC | Prescription | No | AT | 207280 | RISING |
| ACETIC ACID | ACETIC ACID, GLACIAL | 2% | SOLUTION/DROPS;OTIC | Prescription | No | AT | 040607 | SAPTALIS PHARMS |
| ACETIC ACID | ACETIC ACID, GLACIAL | 2% | SOLUTION/DROPS;OTIC | Prescription | No | AT | 088638 | TARO |
| ACETIC ACID | ACETIC ACID, GLACIAL | 2% | SOLUTION/DROPS;OTIC | Prescription | No | AT | 040166 | WOCKHARDT BIO AG |
| VOSOL | ACETIC ACID, GLACIAL | 2% | SOLUTION/DROPS;OTIC | Prescription | No | AT | 012179 | AKORN |
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