Drug - Parcopa
The trade name of the product as shown on the labeling.
TABLET, ORALLY DISINTEGRATING; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Multiple ingredients are in alphabetical order.
The potency of the active ingredient(s), Carbidopa; Levodopa. May repeat for multiple part products.
The firm name holding legal responsibility for Parcopa. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
The FDA assigned number to Parcopa. Format is nnnnnn.
Product Number -
The FDA assigned number to identify Parcopa. 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 -
Aug 27, 2004
The date Parcopa 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) -
The pioneer or innovator of Parcopa. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
The group or category of approved drugs Parcopa is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Schwarz Pharma Inc
The full name of the firm holding legal responsibility for the new application of Parcopa.
Carbilev 25mg;100mg Tablet, For Suspension; Oral Carbilev 25mg;250mg Tablet, For Suspension; Oral Parcopa 10mg;100mg Tablet, Orally Disintegrating; Oral Parcopa 25mg;100mg Tablet, Orally Disintegrating; Oral Carbidopa And Levodopa 50mg;200mg Tablet, Extended Release; Oral Carbidopa And Levodopa 25mg;100mg Tablet, Extended Release; Oral Carbidopa And Levodopa 50mg;200mg Tablet, Extended Release; Oral Sinemet Cr 25mg;100mg Tablet, Extended Release; Oral Sinemet Cr 50mg;200mg Tablet, Extended Release; Oral Carbilev 10mg;100mg Tablet, For Suspension; Oral