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

The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Hydralazine Hydrochloride; Hydrochlorothiazide
Multiple ingredients are in alphabetical order.

Strength - 50MG;50MG
The potency of the active ingredient(s), Hydralazine Hydrochloride; Hydrochlorothiazide. May repeat for multiple part products.

Applicant - NOVARTIS
The firm name holding legal responsibility for Apresazide. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 084810
The FDA assigned number to Apresazide. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Apresazide. 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 Apresazide 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 Apresazide. 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 Apresazide is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novartis Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Apresazide.