Omacor
Drug - Omacor
The trade name of the product as shown on the labeling.
Dosage -
CAPSULE; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Omega-3-acid Ethyl Esters
Multiple ingredients are in alphabetical order.
Strength -
1GM
The potency of the active ingredient(s), Omega-3-acid Ethyl Esters. May repeat for multiple part products.
Applicant -
RELIANT PHARMS INC
The firm name holding legal responsibility for Omacor. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
021654
The FDA assigned number to Omacor. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Omacor. 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 10, 2004
The date Omacor 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 Omacor. 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 Omacor is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Reliant Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Omacor.
Omacor
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