Paracaine

   
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Paracaine


Drug - Paracaine
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) - Proparacaine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 0.5%
The potency of the active ingredient(s), Proparacaine Hydrochloride. May repeat for multiple part products.

Applicant - OPTOPICS
The firm name holding legal responsibility for Paracaine. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 087681
The FDA assigned number to Paracaine. Format is nnnnnn.

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

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

Approval Date - Aug 5, 1982
The date Paracaine 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) - No
The pioneer or innovator of Paracaine. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

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

Applicant Full Name - Optopics Laboratories Corp
The full name of the firm holding legal responsibility for the new application of Paracaine.

Paracaine