Pronestyl-sr
Drug - Pronestyl-sr
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) -
Procainamide Hydrochloride
Multiple ingredients are in alphabetical order.
Strength -
500MG
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-sr. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
087361
The FDA assigned number to Pronestyl-sr. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Pronestyl-sr. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
BC
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-sr 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-sr. 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-sr 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-sr.
Pronestyl-sr
Procan Sr 250mg Tablet, Extended Release; Oral Procan Sr 1gm Tablet, Extended Release; Oral Procan Sr 500mg Tablet, Extended Release; Oral Procan Sr 750mg Tablet, Extended Release; Oral Procanbid 1gm Tablet, Extended Release; Oral Procanbid 500mg Tablet, Extended Release; Oral Pronestyl-sr 500mg Tablet, Extended Release; Oral Procainamide Hcl 500mg Tablet, Extended Release; Oral Procainamide Hcl 750mg Tablet, Extended Release; Oral Procainamide Hcl 750mg Tablet, Extended Release; Oral
NewDrugInformation
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