Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020485
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 AKORN INC
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English