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 -
0.8MG/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 -
006
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 -
BX
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
Minitran 0.6mg/hr Film, Extended Release; Transdermal Nitro-dur 0.1mg/hr Film, Extended Release; Transdermal Nitro-dur 0.2mg/hr Film, Extended Release; Transdermal Nitro-dur 0.3mg/hr Film, Extended Release; Transdermal Nitro-dur 0.4mg/hr Film, Extended Release; Transdermal Nitro-dur 0.6mg/hr Film, Extended Release; Transdermal Nitro-dur 0.8mg/hr Film, Extended Release; Transdermal Minitran 0.1mg/hr Film, Extended Release; Transdermal Minitran 0.2mg/hr Film, Extended Release; Transdermal Minitran 0.4mg/hr Film, Extended Release; Transdermal
NewDrugInformation
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