Diclofenac Sodium
Drug - Diclofenac Sodium
The trade name of the product as shown on the labeling.
Dosage -
TABLET, EXTENDED 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 -
100MG
The potency of the active ingredient(s), Diclofenac Sodium. May repeat for multiple part products.
Applicant -
MYLAN
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 -
076152
The FDA assigned number to Diclofenac Sodium. Format is nnnnnn.
Product Number -
001
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 -
Dec 13, 2001
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 -
Mylan Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Diclofenac Sodium.
Diclofenac Sodium
Diclofenac Sodium 25mg Tablet, Delayed Release; Oral Diclofenac Sodium 50mg Tablet, Delayed Release; Oral Diclofenac Sodium 75mg Tablet, Delayed Release; Oral Voltaren 25mg Tablet, Delayed Release; Oral Voltaren 50mg Tablet, Delayed Release; Oral Voltaren 75mg Tablet, Delayed Release; Oral Diclofenac Sodium 100mg Tablet, Extended Release; Oral Diclofenac Sodium 100mg Tablet, Extended Release; Oral Diclofenac Sodium 100mg Tablet, Extended Release; Oral Diclofenac Sodium 75mg Tablet, Delayed Release; Oral
NewDrugInformation
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