Antara (micronized)

   
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Antara (micronized)


Drug - Antara (micronized)
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) - Fenofibrate
Multiple ingredients are in alphabetical order.

Strength - 87MG
The potency of the active ingredient(s), Fenofibrate. May repeat for multiple part products.

Applicant - RELIANT PHARMS INC
The firm name holding legal responsibility for Antara (micronized). The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021695
The FDA assigned number to Antara (micronized). Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Antara (micronized). 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 30, 2004
The date Antara (micronized) 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 Antara (micronized). The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Antara (micronized) 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 Antara (micronized).

Antara (micronized)