Klonopin Rapidly Disintegrating
Drug - Klonopin Rapidly Disintegrating
The trade name of the product as shown on the labeling.
Dosage -
TABLET, ORALLY DISINTEGRATING; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Clonazepam
Multiple ingredients are in alphabetical order.
Strength -
0.25MG
The potency of the active ingredient(s), Clonazepam. May repeat for multiple part products.
Applicant -
ROCHE
The firm name holding legal responsibility for Klonopin Rapidly Disintegrating. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020813
The FDA assigned number to Klonopin Rapidly Disintegrating. Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Klonopin Rapidly Disintegrating. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Dec 23, 1997
The date Klonopin Rapidly Disintegrating 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 Klonopin Rapidly Disintegrating. 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 Klonopin Rapidly Disintegrating is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Hoffmann La Roche Inc
The full name of the firm holding legal responsibility for the new application of Klonopin Rapidly Disintegrating.
Klonopin Rapidly Disintegrating
Clonazepam 2mg Tablet, Orally Disintegrating; Oral Clonazepam 0.125mg Tablet, Orally Disintegrating; Oral Clonazepam 0.25mg Tablet, Orally Disintegrating; Oral Clonazepam 0.5mg Tablet, Orally Disintegrating; Oral Clonazepam 1mg Tablet, Orally Disintegrating; Oral Clonazepam 2mg Tablet, Orally Disintegrating; Oral Klonopin Rapidly Disintegrating 0.125mg Tablet, Orally Disintegrating; Oral Klonopin Rapidly Disintegrating 0.25mg Tablet, Orally Disintegrating; Oral Clonazepam 0.5mg Tablet, Orally Disintegrating; Oral Clonazepam 1mg Tablet, Orally Disintegrating; Oral
NewDrugInformation
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