Zantac

   
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Zantac


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

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

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

Strength - EQ 15MG BASE/ML
The potency of the active ingredient(s), Ranitidine Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 019675
The FDA assigned number to Zantac. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Zantac. 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 - Dec 30, 1988
The date Zantac 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 Zantac. 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 Zantac is in. Format is RX, OTC, DISCN.

Applicant Full Name - Glaxosmithkline
The full name of the firm holding legal responsibility for the new application of Zantac.

Zantac