Norvasc

   
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Norvasc


Drug - Norvasc
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) - Amlodipine Besylate
Multiple ingredients are in alphabetical order.

Strength - EQ 10MG BASE
The potency of the active ingredient(s), Amlodipine Besylate. May repeat for multiple part products.

Applicant - PFIZER
The firm name holding legal responsibility for Norvasc. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019787
The FDA assigned number to Norvasc. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Norvasc. 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 - Jul 31, 1992
The date Norvasc 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 Norvasc. 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 Norvasc is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pfizer Agricultural Div
The full name of the firm holding legal responsibility for the new application of Norvasc.

Norvasc