Ketorolac Tromethamine

   
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Ketorolac Tromethamine


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

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

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

Strength - 30MG/ML
The potency of the active ingredient(s), Ketorolac Tromethamine. May repeat for multiple part products.

Applicant - APOTEX
The firm name holding legal responsibility for Ketorolac Tromethamine. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 077201
The FDA assigned number to Ketorolac Tromethamine. Format is nnnnnn.

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

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

Approval Date - Oct 14, 2005
The date Ketorolac Tromethamine 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 Ketorolac Tromethamine. 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 Ketorolac Tromethamine is in. Format is RX, OTC, DISCN.

Applicant Full Name - Apotex Corp
The full name of the firm holding legal responsibility for the new application of Ketorolac Tromethamine.

Ketorolac Tromethamine