Diclofenac Sodium

   
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Diclofenac Sodium


Drug - Diclofenac Sodium
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 - 75MG
The potency of the active ingredient(s), Diclofenac Sodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 074514
The FDA assigned number to Diclofenac Sodium. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Diclofenac Sodium. 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 - Mar 26, 1996
The date Diclofenac Sodium 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 Diclofenac Sodium. 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 Diclofenac Sodium 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 Diclofenac Sodium.

Diclofenac Sodium