Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYDRIACYL | TROPICAMIDE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | 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 |
|---|---|---|---|---|---|---|---|
| 12/06/1974 | 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 |
|---|---|---|---|---|---|
| 08/27/2021 | SUPPL-38 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/31/2003 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 12/23/2002 | SUPPL-30 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/07/2000 | SUPPL-29 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/28/2000 | SUPPL-28 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/21/1999 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/2000 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1999 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1999 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1999 | SUPPL-21 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 09/25/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/1997 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1995 | SUPPL-18 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/04/1995 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/14/1993 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/05/1992 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1997 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/04/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/13/1984 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1982 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
MYDRIACYL
SOLUTION/DROPS;OPHTHALMIC; 0.5%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MYDRIACYL | TROPICAMIDE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 084305 | SANDOZ |
| TROPICACYL | TROPICAMIDE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 040314 | EPIC PHARMA LLC |
| TROPICAMIDE | TROPICAMIDE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 040067 | BAUSCH AND LOMB |