Cafcit

   
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Cafcit


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

Dosage - SOLUTION; INTRAVENOUS, ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
The potency of the active ingredient(s), Caffeine Citrate. May repeat for multiple part products.

Applicant - MEAD JOHNSON
The firm name holding legal responsibility for Cafcit. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020793
The FDA assigned number to Cafcit. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Cafcit. 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 - Sep 21, 1999
The date Cafcit 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 Cafcit. 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 Cafcit is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mead Johnson And Co
The full name of the firm holding legal responsibility for the new application of Cafcit.

Cafcit