Verelan Pm
Drug - Verelan Pm
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) -
Verapamil Hydrochloride
Multiple ingredients are in alphabetical order.
Strength -
300MG
The potency of the active ingredient(s), Verapamil Hydrochloride. May repeat for multiple part products.
Applicant -
ELAN DRUG
The firm name holding legal responsibility for Verelan Pm. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020943
The FDA assigned number to Verelan Pm. Format is nnnnnn.
Product Number -
003
The FDA assigned number to identify Verelan Pm. 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 -
Nov 25, 1998
The date Verelan Pm 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) -
Yes
The pioneer or innovator of Verelan Pm. 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 Verelan Pm is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Elan Drug Delivery Inc
The full name of the firm holding legal responsibility for the new application of Verelan Pm.
Verelan Pm
Verapamil Hcl 120mg Capsule, Extended Release; Oral Verapamil Hcl 180mg Capsule, Extended Release; Oral Verapamil Hcl 240mg Capsule, Extended Release; Oral Verelan 120mg Capsule, Extended Release; Oral Verelan 180mg Capsule, Extended Release; Oral Verelan 240mg Capsule, Extended Release; Oral Verelan 360mg Capsule, Extended Release; Oral Verelan Pm 100mg Capsule, Extended Release; Oral Verelan Pm 200mg Capsule, Extended Release; Oral Verelan Pm 300mg Capsule, Extended Release; Oral
NewDrugInformation
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