Dilacor Xr
Drug - Dilacor Xr
The trade name of the product as shown on the labeling.
Dosage -
CAPSULE, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Diltiazem Hydrochloride
Multiple ingredients are in alphabetical order.
Strength -
120MG
The potency of the active ingredient(s), Diltiazem Hydrochloride. May repeat for multiple part products.
Applicant -
WATSON LABS
The firm name holding legal responsibility for Dilacor Xr. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020092
The FDA assigned number to Dilacor Xr. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Dilacor Xr. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
AB2
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
May 29, 1992
The date Dilacor Xr 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 Dilacor Xr. 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 Dilacor Xr is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Watson Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Dilacor Xr.
Dilacor Xr
Dilacor Xr 120mg Capsule, Extended Release; Oral Cardizem Cd 360mg Capsule, Extended Release; Oral Cardizem Sr 120mg Capsule, Extended Release; Oral Cardizem Sr 180mg Capsule, Extended Release; Oral Cardizem Sr 60mg Capsule, Extended Release; Oral Cardizem Sr 90mg Capsule, Extended Release; Oral Cartia Xt 120mg Capsule, Extended Release; Oral Cartia Xt 180mg Capsule, Extended Release; Oral Cartia Xt 240mg Capsule, Extended Release; Oral Cartia Xt 300mg Capsule, Extended Release; Oral
NewDrugInformation
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