Aldoril 15
Drug - Aldoril 15
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; Methyldopa
Multiple ingredients are in alphabetical order.
Strength -
15MG;250MG
The potency of the active ingredient(s), Hydrochlorothiazide; Methyldopa. May repeat for multiple part products.
Applicant -
MERCK
The firm name holding legal responsibility for Aldoril 15. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
013402
The FDA assigned number to Aldoril 15. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Aldoril 15. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Approved Prior to Jan 1, 1982
The date Aldoril 15 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 Aldoril 15. 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 Aldoril 15 is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Merck And Co Inc
The full name of the firm holding legal responsibility for the new application of Aldoril 15.
Aldoril 15
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