crofelemer Delayed Release Oral Tablet
- Brand(s)
- Fulyzaq
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Salix Pharmaceuticals, Inc. (2013-02-22)
- Oldest Current Product
- 2012-12-31
- License(s)
- NDA
- RxNORM
- DELAYED RELEASE ORAL TABLET\CROFELEMER
- FDAOB
- ORAL\TABLET, DELAYED RELEASE\CROFELEMER
- SPL Active
- ORAL\TABLET, COATED\CROFELEMER
- SPL Moiety
- ORAL\TABLET, COATED\CROFELEMER
product(s) by strength(s)
crofelemer 125 mg delayed release oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 656490802 | Fulyzaq | NDA | Salix Pharmaceuticals, Inc. | 2012-12-31 | CROFELEMER | ORAL | TABLET, COATED | NDA202292 | 684ca8ce-2583-4c2d-a283-8a16fc63f8f8 |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA202292 | FULYZAQ | SALIX PHARMACEUTICALS INC | 2012-12-31 | p8962680, SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA p7341744, SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA p7323195, SUBSTANCE p8574634, SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA | NEW CHEMICAL ENTITY [2017-12-31] | NDA202292_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA202292_001 | RX | CROFELEMER (125MG) | ORAL | TABLET, DELAYED RELEASE | True | 2012-12-31 | FULYZAQ |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p7323195 (view patent) | 2018-06-07 | NDA202292 |
| 2 | p7341744 (view patent) | 2018-06-16 | NDA202292 |
| 3 | p8574634 (view patent) | 2018-01-11 | NDA202292 |
| 4 | p8962680 (view patent) | 2031-10-31 | NDA202292 |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | 684ca8ce-2583-4c2d-a283-8a16fc63f8f8 (view SPL) | These highlights do not include all the information needed to useFULYZAQ safely and effectively. See full prescribing information forFULYZAQ. FULYZAQ (crofelemer)delayed-release tabletsfororal use Initial U.S. Approval: 2012 | prescription | Human Prescription | Salix Pharmaceuticals, Inc. | 2013-02-22 | 26 | 656490802 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII