Verelan

   
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Verelan


Drug - Verelan
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 - 360MG
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. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019614
The FDA assigned number to Verelan. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Verelan. 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 - May 10, 1996
The date Verelan 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. 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 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.

Verelan