Drugs@FDA: FDA-Approved Drugs
Company: ALCON LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALCAINE | PROPARACAINE HYDROCHLORIDE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | 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 |
|---|---|---|---|---|---|---|---|
| 12/22/1971 | 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 |
|---|---|---|---|---|---|
| 05/30/2024 | SUPPL-51 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/09/2022 | SUPPL-47 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/04/2005 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 08/06/2003 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 12/23/2002 | SUPPL-32 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/01/2001 | SUPPL-31 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 03/01/2001 | SUPPL-30 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/11/2000 | SUPPL-29 | Labeling |
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-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1999 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1999 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1999 | SUPPL-24 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/11/2000 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1996 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 10/05/1995 | SUPPL-21 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/04/1995 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1993 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/04/1993 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/21/1989 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 05/17/1989 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 04/27/1989 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1987 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
ALCAINE
SOLUTION/DROPS;OPHTHALMIC; 0.5%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALCAINE | PROPARACAINE HYDROCHLORIDE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 080027 | ALCON LABS INC |
| PROPARACAINE HYDROCHLORIDE | PROPARACAINE HYDROCHLORIDE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 040074 | BAUSCH AND LOMB |
| PROPARACAINE HYDROCHLORIDE | PROPARACAINE HYDROCHLORIDE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 040277 | RISING |