Hydralazine Hcl

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Hydralazine Hcl

Drug - Hydralazine Hcl
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
Multiple ingredients are in alphabetical order.

Strength - 25MG
The potency of the active ingredient(s), Hydralazine Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 087712
The FDA assigned number to Hydralazine Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Hydralazine Hcl. 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 - Approved Prior to Jan 1, 1982
The date Hydralazine 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 Hydralazine Hcl. 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 Hydralazine Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Vangard Laboratories Inc Div Midway Medical Co
The full name of the firm holding legal responsibility for the new application of Hydralazine Hcl.

Hydralazine Hcl