Ranitidine Hcl

   
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Ranitidine Hcl


Drug - Ranitidine Hcl
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 300MG BASE
The potency of the active ingredient(s), Ranitidine Hydrochloride. May repeat for multiple part products.

Applicant - BOEHRINGER INGELHEIM
The firm name holding legal responsibility for Ranitidine Hcl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 074662
The FDA assigned number to Ranitidine Hcl. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Ranitidine Hcl. 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 29, 1997
The date Ranitidine Hcl 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 Ranitidine Hcl. 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 Ranitidine Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Boehringer Ingelheim Corp
The full name of the firm holding legal responsibility for the new application of Ranitidine Hcl.

Ranitidine Hcl