Tropicamide

   
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Tropicamide


Drug - Tropicamide
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) - Tropicamide
Multiple ingredients are in alphabetical order.

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

Applicant - MIZA PHARMS USA
The firm name holding legal responsibility for Tropicamide. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 087636
The FDA assigned number to Tropicamide. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Tropicamide. 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 - Jul 30, 1982
The date Tropicamide 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 Tropicamide. 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 Tropicamide is in. Format is RX, OTC, DISCN.

Applicant Full Name - Miza Pharmaceuticals Usa Inc
The full name of the firm holding legal responsibility for the new application of Tropicamide.

Tropicamide