Amlodipine Besylate

   
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Amlodipine Besylate


Drug - Amlodipine Besylate
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 - MYLAN
The firm name holding legal responsibility for Amlodipine Besylate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076418
The FDA assigned number to Amlodipine Besylate. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Amlodipine Besylate. 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 - Oct 3, 2005
The date Amlodipine Besylate 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 Amlodipine Besylate. 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 Amlodipine Besylate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mylan Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Amlodipine Besylate.

Amlodipine Besylate