Imdur

   
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Imdur


Drug - Imdur
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 - 60MG
The potency of the active ingredient(s), Isosorbide Mononitrate. May repeat for multiple part products.

Applicant - SCHERING PLOUGH
The firm name holding legal responsibility for Imdur. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020225
The FDA assigned number to Imdur. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Imdur. 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 - Aug 12, 1993
The date Imdur 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 Imdur. 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 Imdur is in. Format is RX, OTC, DISCN.

Applicant Full Name - Schering Plough Corp
The full name of the firm holding legal responsibility for the new application of Imdur.

Imdur