Drugs@FDA: FDA-Approved Drugs
Company: ALCON LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOGYL | CYCLOPENTOLATE HYDROCHLORIDE | 1% | 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 |
|---|---|---|---|---|---|---|---|
| 07/31/1974 | 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 |
|---|---|---|---|---|---|
| 10/31/2003 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 12/23/2002 | SUPPL-35 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 10/11/2002 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/20/2001 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/07/2000 | SUPPL-32 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/28/2000 | SUPPL-31 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/23/1999 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1999 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1999 | SUPPL-27 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 02/17/1998 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1995 | SUPPL-25 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/04/1995 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/1994 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1994 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 01/16/1997 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 12/02/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/05/1992 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1992 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 06/04/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/20/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/20/1991 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/13/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/28/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 03/09/1989 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/1988 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 12/08/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/12/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
CYCLOGYL
SOLUTION/DROPS;OPHTHALMIC; 1%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AKPENTOLATE | CYCLOPENTOLATE HYDROCHLORIDE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 040164 | RISING |
| CYCLOGYL | CYCLOPENTOLATE HYDROCHLORIDE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 084110 | ALCON LABS INC |
| PENTOLAIR | CYCLOPENTOLATE HYDROCHLORIDE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 040075 | BAUSCH AND LOMB |