Uniretic

   
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Uniretic


Drug - Uniretic
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; Moexipril Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 12.5MG;7.5MG
The potency of the active ingredient(s), Hydrochlorothiazide; Moexipril Hydrochloride. May repeat for multiple part products.

Applicant - SCHWARZ PHARMA
The firm name holding legal responsibility for Uniretic. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020729
The FDA assigned number to Uniretic. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Uniretic. 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 - Jun 27, 1997
The date Uniretic 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 Uniretic. 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 Uniretic is in. Format is RX, OTC, DISCN.

Applicant Full Name - Schwarz Pharma Inc
The full name of the firm holding legal responsibility for the new application of Uniretic.

Uniretic