Zantac 25

   
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Zantac 25


Drug - Zantac 25
The trade name of the product as shown on the labeling.

Dosage - TABLET, EFFERVESCENT; 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 25MG BASE
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 25. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020251
The FDA assigned number to Zantac 25. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Zantac 25. 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 - Apr 1, 2004
The date Zantac 25 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 Zantac 25. 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 25 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 25.

Zantac 25