Altoprev

   
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Altoprev


Drug - Altoprev
The trade name of the product as shown on the labeling.

Dosage - TABLET, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Lovastatin
Multiple ingredients are in alphabetical order.

Strength - 20MG
The potency of the active ingredient(s), Lovastatin. May repeat for multiple part products.

Applicant - ANDRX LABS LLC
The firm name holding legal responsibility for Altoprev. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021316
The FDA assigned number to Altoprev. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Altoprev. 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 - Jun 26, 2002
The date Altoprev 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 Altoprev. 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 Altoprev is in. Format is RX, OTC, DISCN.

Applicant Full Name - Andrx Labs Llc
The full name of the firm holding legal responsibility for the new application of Altoprev.

Altoprev