Voltaren

   
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Voltaren


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

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

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

Strength - 25MG
The potency of the active ingredient(s), Diclofenac Sodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 019201
The FDA assigned number to Voltaren. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Voltaren. 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 - Jul 28, 1988
The date Voltaren 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 Voltaren. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Voltaren is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novartis Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Voltaren.

Voltaren