Pronestyl

   
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Pronestyl


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

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

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

Strength - 375MG
The potency of the active ingredient(s), Procainamide Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 017371
The FDA assigned number to Pronestyl. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Pronestyl. 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 - Approved Prior to Jan 1, 1982
The date Pronestyl 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 Pronestyl. 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 Pronestyl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Apothecon Inc Div Bristol Myers Squibb
The full name of the firm holding legal responsibility for the new application of Pronestyl.

Pronestyl