Ismo

   
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Ismo


Drug - Ismo
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) - Isosorbide Mononitrate
Multiple ingredients are in alphabetical order.

Strength - 20MG
The potency of the active ingredient(s), Isosorbide Mononitrate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 019091
The FDA assigned number to Ismo. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Ismo. 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 30, 1991
The date Ismo 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 Ismo. 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 Ismo is in. Format is RX, OTC, DISCN.

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

Ismo