Zantac 75

   
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Zantac 75


Drug - Zantac 75
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 75MG BASE
The potency of the active ingredient(s), Ranitidine Hydrochloride. May repeat for multiple part products.

Applicant - WARNER LAMBERT
The firm name holding legal responsibility for Zantac 75. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020520
The FDA assigned number to Zantac 75. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Zantac 75. 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 19, 1995
The date Zantac 75 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 75. 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 75 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Warner Lambert Co
The full name of the firm holding legal responsibility for the new application of Zantac 75.

Zantac 75