Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020226
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
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
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 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

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