An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020065
Company: BAUSCH AND LOMB

Products on NDA 020065

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020065

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
09/23/2022	SUPPL-33	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020065Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020065Orig1s033ltr.pdf
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.

Labels for NDA 020065

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2022	SUPPL-33	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020065Orig1s033lbl.pdf
07/31/2007	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020065s017lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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

Top