Drugs@FDA: FDA-Approved Drugs
Company: JOHNSON AND JOHNSON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VISINE | 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 |
---|---|---|---|---|---|---|---|
01/31/1996 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
---|---|---|---|---|---|
10/17/2018 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020485Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020485Orig1s013ltr.pdf | |
01/06/2017 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/26/2016 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020485Orig1s011lbl.pdf | |
03/10/2016 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/18/2012 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020485Orig1s009Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020485Orig1s009ltr.pdf | |
10/15/2004 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20485s007ltr.pdf |
09/15/2003 | SUPPL-6 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20485scm006_visine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20485scm006ltr.pdf | |
06/14/2002 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20485s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20485s005ltr.pdf | |
03/11/1999 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/19/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
09/26/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
12/26/1996 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/17/2018 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020485Orig1s013lbl.pdf | |
08/26/2016 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020485Orig1s011lbl.pdf | |
12/18/2012 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020485Orig1s009Lbl.pdf | |
09/15/2003 | SUPPL-6 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20485scm006_visine_lbl.pdf |
06/14/2002 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20485s005lbl.pdf |
VISINE
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 |