Visine L.R.

   
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Visine L.R.


Drug - Visine L.R.
The trade name of the product as shown on the labeling.

Dosage - SOLUTION/DROPS; OPHTHALMIC
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Oxymetazoline Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 0.025%
The potency of the active ingredient(s), Oxymetazoline Hydrochloride. May repeat for multiple part products.

Applicant - PFIZER
The firm name holding legal responsibility for Visine L.R.. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019407
The FDA assigned number to Visine L.R.. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Visine L.R.. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code -
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Mar 31, 1989
The date Visine L.R. was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - Yes
The pioneer or innovator of Visine L.R.. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - OTC
The group or category of approved drugs Visine L.R. is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pfizer Laboratories Div Pfizer Inc
The full name of the firm holding legal responsibility for the new application of Visine L.R..

Visine L.R.