Nitrol

   
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Nitrol


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

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

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

Strength - 0.8MG/ML
The potency of the active ingredient(s), Nitroglycerin. May repeat for multiple part products.

Applicant - RORER
The firm name holding legal responsibility for Nitrol. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018774
The FDA assigned number to Nitrol. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Nitrol. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Jan 19, 1983
The date Nitrol 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 Nitrol. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Nitrol is in. Format is RX, OTC, DISCN.

Applicant Full Name - Rorer Pharmaceutical Corp Sub Rorer Group
The full name of the firm holding legal responsibility for the new application of Nitrol.

Nitrol