Drugs@FDA: FDA-Approved Drugs
Company: ALCON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NAPHCON-A | NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE | 0.025%;0.3% | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | None | 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 |
|---|---|---|---|---|---|---|---|
| 06/08/1994 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/19/2022 | SUPPL-35 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020226Orig1s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020226Orig1s035ltr.pdf | |
| 04/11/2019 | SUPPL-29 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020226Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020226Orig1s029ltr.pdf | |
| 07/31/2015 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/2014 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/22/2000 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/2000 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/21/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1999 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/1999 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/14/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/1999 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/20/1998 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/23/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1996 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/16/1996 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/30/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/23/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/04/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/19/2022 | SUPPL-35 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020226Orig1s035lbl.pdf | |
| 04/11/2019 | SUPPL-29 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020226Orig1s029lbl.pdf |
NAPHCON-A
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SOLUTION/DROPS;OPHTHALMIC; 0.025%;0.3%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE | 0.025%;0.3% | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 202795 | RISING |
| NAPHCON-A | NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE | 0.025%;0.3% | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | Yes | 020226 | ALCON |
| VISINE | NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE | 0.025%;0.3% | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | Yes | 020485 | JOHNSON AND JOHNSON |