Trandate Hct
Drug - Trandate Hct
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) -
Hydrochlorothiazide; Labetalol Hydrochloride
Multiple ingredients are in alphabetical order.
Strength -
25MG;200MG
The potency of the active ingredient(s), Hydrochlorothiazide; Labetalol Hydrochloride. May repeat for multiple part products.
Applicant -
GLAXOSMITHKLINE
The firm name holding legal responsibility for Trandate Hct. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
019174
The FDA assigned number to Trandate Hct. Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Trandate Hct. 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 -
Apr 10, 1987
The date Trandate Hct 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 Trandate Hct. 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 Trandate Hct 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 Trandate Hct.
Trandate Hct
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