Tagamet Hb 200
Drug - Tagamet Hb 200
The trade name of the product as shown on the labeling.
Dosage -
SUSPENSION; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Cimetidine
Multiple ingredients are in alphabetical order.
Strength -
200MG/20ML
The potency of the active ingredient(s), Cimetidine. May repeat for multiple part products.
Applicant -
GLAXOSMITHKLINE
The firm name holding legal responsibility for Tagamet Hb 200. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020951
The FDA assigned number to Tagamet Hb 200. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Tagamet Hb 200. 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 -
Jul 9, 1999
The date Tagamet Hb 200 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 Tagamet Hb 200. 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 Tagamet Hb 200 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 Tagamet Hb 200.
Tagamet Hb 200
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