Diclofenac sodium is the generic ingredient in seven branded drugs marketed by Tolmar, Fougera Pharms, Novartis, Akorn, Alcon Pharms Ltd, Apotex Inc, Bausch And Lomb, Falcon Pharms, Nexus Pharms, Mallinckrodt, Mallinckrodt Inc, Actavis Elizabeth, Carlsbad, Mylan Pharms Inc, Nostrum Labs, Pliva, Roxane, Sandoz, Teva, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Mylan, Valeant Intl, Gd Searle Llc, Actavis Labs Fl Inc, and Eagle Pharms, and is included in thirty-six NDAs. There are fifteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.
There are fourty-six drug master file entries for diclofenac sodium. Twenty suppliers are listed for this compound. There is one tentative approval for this compound.
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Type||RLD||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|TABLET, DELAYED RELEASE;ORAL||074391||Jun 29, 1995||DISCN||No||<disabled>||<disabled>|
|SOLUTION;TOPICAL||020947||Nov 4, 2009||RX||Yes||8,217,078||<disabled>||<disabled>|
|TABLET, EXTENDED RELEASE;ORAL||076152||Dec 13, 2001||RX||No||<disabled>||<disabled>|
|GEL;TOPICAL||021005||Oct 16, 2000||RX||Yes||5,929,048||<disabled>||<disabled>|
|TABLET, DELAYED RELEASE;ORAL||019201||Jul 28, 1988||DISCN||No||<disabled>||<disabled>|
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