Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019407
Company: JOHNSON AND JOHNSON
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
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.

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 JOHNSON AND JOHNSON

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