Zantac In Plastic Container

   
Google
 
Web NewDrugInformation.com

Zantac In Plastic Container


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

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

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

Strength - EQ 50MG BASE/100ML
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 In Plastic Container. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019593
The FDA assigned number to Zantac In Plastic Container. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Zantac In Plastic Container. 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 17, 1986
The date Zantac In Plastic Container 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 In Plastic Container. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Zantac In Plastic Container 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 In Plastic Container.

Zantac In Plastic Container