Opcon-a

   
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Opcon-a


Drug - Opcon-a
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) - Naphazoline Hydrochloride; Pheniramine Maleate
Multiple ingredients are in alphabetical order.

Strength - 0.02675%;0.315%
The potency of the active ingredient(s), Naphazoline Hydrochloride; Pheniramine Maleate. May repeat for multiple part products.

Applicant - BAUSCH AND LOMB
The firm name holding legal responsibility for Opcon-a. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020065
The FDA assigned number to Opcon-a. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Opcon-a. 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 - Jun 8, 1994
The date Opcon-a 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 Opcon-a. 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 Opcon-a is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bausch And Lomb Inc
The full name of the firm holding legal responsibility for the new application of Opcon-a.

Opcon-a