Lovastatin

   
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Lovastatin


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

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

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

Strength - 40MG
The potency of the active ingredient(s), Lovastatin. May repeat for multiple part products.

Applicant - PUREPAC PHARM
The firm name holding legal responsibility for Lovastatin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 075828
The FDA assigned number to Lovastatin. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Lovastatin. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Dec 17, 2001
The date Lovastatin 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 Lovastatin. 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 Lovastatin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Purepac Pharmaceutical Co
The full name of the firm holding legal responsibility for the new application of Lovastatin.

Lovastatin