Nitro-dur

   
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Nitro-dur


Drug - Nitro-dur
The trade name of the product as shown on the labeling.

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

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

Strength - 0.6MG/HR
The potency of the active ingredient(s), Nitroglycerin. May repeat for multiple part products.

Applicant - KEY PHARMS
The firm name holding legal responsibility for Nitro-dur. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020145
The FDA assigned number to Nitro-dur. Format is nnnnnn.

Product Number - 005
The FDA assigned number to identify Nitro-dur. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB1
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Apr 4, 1995
The date Nitro-dur 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 Nitro-dur. 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 Nitro-dur is in. Format is RX, OTC, DISCN.

Applicant Full Name - Key Pharmaceuticals Inc Sub Schering Plough Corp
The full name of the firm holding legal responsibility for the new application of Nitro-dur.

Nitro-dur