Cartia Xt
Drug - Cartia Xt
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 -
ANDRX PHARMS
The firm name holding legal responsibility for Cartia Xt. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
074752
The FDA assigned number to Cartia Xt. Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Cartia Xt. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
AB3
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Jul 9, 1998
The date Cartia Xt 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 Cartia Xt. 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 Cartia Xt is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Andrx Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Cartia Xt.
Cartia Xt
Cardizem Cd 300mg 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 Cardizem Cd 120mg Capsule, Extended Release; Oral Cardizem Cd 180mg Capsule, Extended Release; Oral Cardizem Cd 240mg Capsule, Extended Release; Oral
NewDrugInformation
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