Arthrotec
Drug - Arthrotec
The trade name of the product as shown on the labeling.
Dosage -
TABLET, DELAYED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Diclofenac Sodium; Misoprostol
Multiple ingredients are in alphabetical order.
Strength -
50MG;0.2MG
The potency of the active ingredient(s), Diclofenac Sodium; Misoprostol. May repeat for multiple part products.
Applicant -
GD SEARLE LLC
The firm name holding legal responsibility for Arthrotec. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020607
The FDA assigned number to Arthrotec. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Arthrotec. 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 -
Dec 24, 1997
The date Arthrotec 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 Arthrotec. 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 Arthrotec is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Gd Searle Llc
The full name of the firm holding legal responsibility for the new application of Arthrotec.
Arthrotec
Voltaren-xr 100mg Tablet, Extended Release; Oral Arthrotec 50mg;0.2mg Tablet, Delayed Release; Oral Diclofenac Sodium 75mg Tablet, Delayed Release; Oral Voltaren 25mg Tablet, Delayed Release; Oral Voltaren 50mg Tablet, Delayed Release; Oral Voltaren 75mg Tablet, Delayed Release; Oral Diclofenac Sodium 100mg Tablet, Extended Release; Oral Diclofenac Sodium 100mg Tablet, Extended Release; Oral Diclofenac Sodium 100mg Tablet, Extended Release; Oral Diclofenac Sodium 100mg Tablet, Extended Release; Oral
NewDrugInformation
|