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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019407
Company: KENVUE BRANDS

Products on NDA 019407

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VISINE L.R.	OXYMETAZOLINE HYDROCHLORIDE	0.025%	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019407

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/31/1989	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
11/01/2002	SUPPL-10	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19407slr010ltr.pdf
01/11/2002	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/10/2000	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/15/1999	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/17/1998	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/05/1998	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/03/1995	SUPPL-4	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
02/13/1990	SUPPL-2	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
10/27/1989	SUPPL-1	Labeling		Label is not available on this site.

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

VISINE L.R.

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%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
VISINE L.R.	OXYMETAZOLINE HYDROCHLORIDE	0.025%	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	Yes	019407	KENVUE BRANDS

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