Isosorbide Mononitrate

   
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Isosorbide Mononitrate


Drug - Isosorbide Mononitrate
The trade name of the product as shown on the labeling.

Dosage - TABLET, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Isosorbide Mononitrate
Multiple ingredients are in alphabetical order.

Strength - 30MG
The potency of the active ingredient(s), Isosorbide Mononitrate. May repeat for multiple part products.

Applicant - PUREPAC PHARM
The firm name holding legal responsibility for Isosorbide Mononitrate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 075306
The FDA assigned number to Isosorbide Mononitrate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Isosorbide Mononitrate. 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 31, 1998
The date Isosorbide Mononitrate 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 Isosorbide Mononitrate. 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 Isosorbide Mononitrate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Purepac Pharmaceutical Co
The full name of the firm holding legal responsibility for the new application of Isosorbide Mononitrate.

Isosorbide Mononitrate