Dilt-cd
Drug - Dilt-cd
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 -
TORPHARM
The firm name holding legal responsibility for Dilt-cd. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
076151
The FDA assigned number to Dilt-cd. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Dilt-cd. 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 -
May 20, 2004
The date Dilt-cd 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 Dilt-cd. 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 Dilt-cd is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Torpharm Inc
The full name of the firm holding legal responsibility for the new application of Dilt-cd.
Dilt-cd
Dilacor Xr 120mg Capsule, Extended Release; Oral Dilacor Xr 180mg Capsule, Extended Release; Oral Dilacor Xr 240mg Capsule, Extended Release; Oral Dilt-cd 120mg 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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