Procan Sr
Drug - Procan 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 -
750MG
The potency of the active ingredient(s), Procainamide Hydrochloride. May repeat for multiple part products.
Applicant -
PARKEDALE
The firm name holding legal responsibility for Procan Sr. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
087510
The FDA assigned number to Procan Sr. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Procan Sr. 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 -
Apr 1, 1982
The date Procan 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 Procan Sr. 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 Procan Sr is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Parkedale Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Procan Sr.
Procan 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 Procainamide Hcl 250mg Tablet, Extended Release; Oral Procainamide Hcl 250mg Tablet, Extended Release; Oral Procainamide Hcl 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
|