Drugs@FDA: FDA-Approved Drugs
Company: ALCON LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOMYDRIL | CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE | 0.2%;1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 09/12/1975 | 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-32 | Labeling |
Label is not available on this site. |
||
| 12/19/2002 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/23/2002 | SUPPL-29 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/07/2000 | SUPPL-28 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/18/2001 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/18/2001 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/18/2001 | SUPPL-25 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 04/18/2001 | SUPPL-24 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/28/2000 | SUPPL-23 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/23/1999 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1999 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1999 | SUPPL-20 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/18/1996 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1996 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1995 | SUPPL-16 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/04/1994 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/24/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 11/05/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/24/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/04/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/09/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |