Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020065
Company: BAUSCH AND LOMB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OPCON-A NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE 0.02675%;0.315% 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 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
03/14/2016 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/18/2015 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/12/2015 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/31/2007 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020065s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020065s017ltr.pdf
12/18/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/23/1996 SUPPL-14 Labeling

Label is not available on this site.

07/23/1996 SUPPL-13 Labeling

Label is not available on this site.

05/09/1996 SUPPL-11 Labeling

Label is not available on this site.

04/20/2005 SUPPL-10 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020065s010ltr.pdf
03/13/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/11/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/11/1995 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/29/1994 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1994 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/11/1994 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/31/2007 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020065s017lbl.pdf

OPCON-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; 0.02675%;0.315%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE 0.02675%;0.315% SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 078208 ALTAIRE PHARMS INC
OPCON-A NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE 0.02675%;0.315% SOLUTION/DROPS;OPHTHALMIC Over-the-counter Yes 020065 BAUSCH AND LOMB

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