Moduretic 5-50


Moduretic 5-50

Drug - Moduretic 5-50
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 - MERCK
The firm name holding legal responsibility for Moduretic 5-50. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018201
The FDA assigned number to Moduretic 5-50. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Moduretic 5-50. 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 Moduretic 5-50 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) - Yes
The pioneer or innovator of Moduretic 5-50. 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 Moduretic 5-50 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Merck Research Laboratories Div Merck Co Inc
The full name of the firm holding legal responsibility for the new application of Moduretic 5-50.

Moduretic 5-50