Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088759
Company: TARO
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCORTISONE AND ACETIC ACID | ACETIC ACID, GLACIAL; HYDROCORTISONE | 2%;1% | SOLUTION/DROPS;OTIC | Prescription | AT | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/04/1985 | 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 |
|---|---|---|---|---|---|
| 04/28/2005 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/24/1999 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 06/13/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1993 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 10/01/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 04/28/1992 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 07/17/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 03/27/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/19/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/01/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
HYDROCORTISONE AND ACETIC ACID
SOLUTION/DROPS;OTIC; 2%;1%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDROCORTISONE AND ACETIC ACID | ACETIC ACID, GLACIAL; HYDROCORTISONE | 2%;1% | SOLUTION/DROPS;OTIC | Prescription | No | AT | 040609 | COSETTE |
| HYDROCORTISONE AND ACETIC ACID | ACETIC ACID, GLACIAL; HYDROCORTISONE | 2%;1% | SOLUTION/DROPS;OTIC | Prescription | Yes | AT | 088759 | TARO |
| VOSOL HC | ACETIC ACID, GLACIAL; HYDROCORTISONE | 2%;1% | SOLUTION/DROPS;OTIC | Prescription | Yes | AT | 012770 | SAPTALIS PHARMS |