Ketalar

   
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Ketalar


Drug - Ketalar
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) - Ketamine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - EQ 100MG BASE/ML
The potency of the active ingredient(s), Ketamine Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 016812
The FDA assigned number to Ketalar. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Ketalar. 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 - Approved Prior to Jan 1, 1982
The date Ketalar 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 Ketalar. 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 Ketalar is in. Format is RX, OTC, DISCN.

Applicant Full Name - Parkedale Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Ketalar.

Ketalar