Monopril-hct

   
Google
 
Web NewDrugInformation.com

Monopril-hct


Drug - Monopril-hct
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) - Fosinopril Sodium; Hydrochlorothiazide
Multiple ingredients are in alphabetical order.

Strength - 10MG;12.5MG
The potency of the active ingredient(s), Fosinopril Sodium; Hydrochlorothiazide. May repeat for multiple part products.

Applicant - BRISTOL MYERS SQUIBB
The firm name holding legal responsibility for Monopril-hct. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020286
The FDA assigned number to Monopril-hct. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Monopril-hct. 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 - Nov 30, 1994
The date Monopril-hct 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 Monopril-hct. 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 Monopril-hct is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bristol Myers Squibb
The full name of the firm holding legal responsibility for the new application of Monopril-hct.

Monopril-hct