Zantac 150

   
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Zantac 150


Drug - Zantac 150
The trade name of the product as shown on the labeling.

Dosage - TABLET; 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 150MG BASE
The potency of the active ingredient(s), Ranitidine Hydrochloride. May repeat for multiple part products.

Applicant - PFIZER CONS HLTHCARE
The firm name holding legal responsibility for Zantac 150. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021698
The FDA assigned number to Zantac 150. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Zantac 150. 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 - Aug 31, 2004
The date Zantac 150 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 150. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - OTC
The group or category of approved drugs Zantac 150 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pfizer Consumer Healthcare Div Warner Lambert Co
The full name of the firm holding legal responsibility for the new application of Zantac 150.

Zantac 150