FDA Orange Book · active-ingredient family
Carisoprodol
Carisoprodol is approved as 2 brand and 24 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SOMA · NDA 011792
2
Brand (NDA)
24
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet
Generic (ANDA) products (24)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CARISOPRODOL | POINTVIEW HLDINGS | ANDA 211789 | AA | Oct 20, 2021 | |
| CARISOPRODOL×2 | MPP PHARMA | ANDA 207237 | AB | May 11, 2017 | |
| CARISOPRODOL×2 | AUROBINDO PHARMA | ANDA 040792 | AB | Nov 08, 2016 | |
| CARISOPRODOL×2 | STRIDES PHARMA | ANDA 205513 | — | Nov 12, 2015 | |
| CARISOPRODOL×2 | HERITAGE | ANDA 205126 | AB | Jul 08, 2015 | |
| CARISOPRODOL | NATCO | ANDA 090988 | AA | Oct 28, 2014 | |
| CARISOPRODOL | ORIENT PHARMA CO LTD | ANDA 205085 | AA | Oct 28, 2014 | |
| CARISOPRODOL | SCIEGEN PHARMS | ANDA 203374 | AA | Jan 27, 2014 | |
| CARISOPRODOL | INGENUS PHARMS LLC | ANDA 040823 | AA | Oct 22, 2008 | |
| CARISOPRODOL | SUN PHARM INDS LTD | ANDA 040755 | — | Feb 27, 2007 | |
| CARISOPRODOL | ACCELRX LABS | ANDA 040576 | AA | Jun 07, 2005 | |
| CARISOPRODOL | ABLE | ANDA 040421 | — | Jun 21, 2001 | |
| CARISOPRODOL | EPIC PHARMA LLC | ANDA 040397 | — | Sep 21, 2000 | |
| CARISOPRODOL | CHARTWELL RX | ANDA 040245 | AA | Sep 08, 1997 | |
| CARISOPRODOL | OXFORD PHARMS | ANDA 040188 | AA | Mar 07, 1997 | |
| CARISOPRODOL | WATSON LABS | ANDA 040152 | — | Dec 03, 1996 | |
| CARISOPRODOL | HIKMA INTL PHARMS | ANDA 040124 | — | Jan 24, 1996 | |
| CARISOPRODOL | SUN PHARM INDUSTRIES | ANDA 089346 | — | Oct 17, 1991 | |
| CARISOPRODOL | SENORES PHARMS | ANDA 081025 | AA | Apr 13, 1989 | |
| CARISOPRODOL | PIONEER PHARMS | ANDA 089390 | — | Oct 13, 1988 | |
| CARISOPRODOL | SANDOZ | ANDA 089566 | — | Aug 30, 1988 | |
| CARISOPRODOL | WATSON LABS | ANDA 087499 | AA | Apr 20, 1982 | |
| CARISOPRODOL | WATSON LABS | ANDA 085433 | — | Approved Prior to Jan 1, 1982 | |
| CARISOPRODOL | WATSON LABS TEVA | ANDA 086179 | — | Approved Prior to Jan 1, 1982 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Carisoprodol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
