Catarase

   
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Catarase


Drug - Catarase
The trade name of the product as shown on the labeling.

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

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

Strength - 300 UNITS/VIAL
The potency of the active ingredient(s), Chymotrypsin. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 016938
The FDA assigned number to Catarase. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Catarase. 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 - Approved Prior to Jan 1, 1982
The date Catarase 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 Catarase. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

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

Applicant Full Name - Ciba Vision Corp Div Novartis Co
The full name of the firm holding legal responsibility for the new application of Catarase.

Catarase