Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088638
Company: TARO
Company: TARO
| 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 |
|---|---|---|---|---|---|---|---|
| 09/06/1984 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/30/2001 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 11/22/1999 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 04/06/1993 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 03/15/1993 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 12/20/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/31/1989 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/11/1988 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/01/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1984 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1984 | SUPPL-1 | Manufacturing (CMC) |
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 |