Cimetidine Hcl

   
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Cimetidine Hcl


Drug - Cimetidine Hcl
The trade name of the product as shown on the labeling.

Dosage - SOLUTION; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - EQ 300MG BASE/5ML
The potency of the active ingredient(s), Cimetidine Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 074610
The FDA assigned number to Cimetidine Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Cimetidine Hcl. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AA
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Sep 26, 1996
The date Cimetidine 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 Cimetidine Hcl. 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 Cimetidine Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Teva Pharmaceuticals Usa Inc
The full name of the firm holding legal responsibility for the new application of Cimetidine Hcl.

Cimetidine Hcl