Web NewDrugInformation.com


Drug - Hydro-ride
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) - Amiloride Hydrochloride; Hydrochlorothiazide
Multiple ingredients are in alphabetical order.

Strength - EQ 5MG ANHYDROUS;50MG
The potency of the active ingredient(s), Amiloride Hydrochloride; Hydrochlorothiazide. May repeat for multiple part products.

Applicant - PAR PHARM
The firm name holding legal responsibility for Hydro-ride. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 070347
The FDA assigned number to Hydro-ride. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Hydro-ride. 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 - Dec 25, 1990
The date Hydro-ride 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 Hydro-ride. 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 Hydro-ride is in. Format is RX, OTC, DISCN.

Applicant Full Name - Par Pharmaceutical Inc
The full name of the firm holding legal responsibility for the new application of Hydro-ride.