Monopril

   
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Monopril


Drug - Monopril
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
Multiple ingredients are in alphabetical order.

Strength - 40MG
The potency of the active ingredient(s), Fosinopril Sodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 019915
The FDA assigned number to Monopril. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Monopril. 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 - Mar 28, 1995
The date Monopril 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 Monopril. 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 is in. Format is RX, OTC, DISCN.

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

Monopril