Lipitor
Drug - Lipitor
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) -
Atorvastatin Calcium
Multiple ingredients are in alphabetical order.
Strength -
EQ 10MG BASE
The potency of the active ingredient(s), Atorvastatin Calcium. May repeat for multiple part products.
Applicant -
PFIZER
The firm name holding legal responsibility for Lipitor. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020702
The FDA assigned number to Lipitor. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Lipitor. 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 -
Dec 17, 1996
The date Lipitor 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 Lipitor. 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 Lipitor is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Pfizer Inc
The full name of the firm holding legal responsibility for the new application of Lipitor.
Lipitor
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