sodium phosphate Oral Tablet
- Brand(s)
- OsmoPrep
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Salix Pharmaceuticals, Inc. (2013-03-27)
- Oldest Current Product
- 2006-05-15
- License(s)
- NDA
- RxNORM
- ORAL TABLET\SODIUM PHOSPHATE
- FDAOB
- ORAL\TABLET\SODIUM PHOSPHATE, DIBASIC, ANHYDROUS: SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
- SPL Active
- ORAL\TABLET\SODIUM PHOSPHATE, DIBASIC, ANHYDROUS: SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
- SPL Moiety
- ORAL\TABLET\PHOSPHATE ION
ORAL\TABLET\SODIUM CATION
product(s) by strength(s)
sodium phosphate 1500 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 656490701 | OsmoPrep | NDA | Salix Pharmaceuticals, Inc. | 2006-05-15 | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | ORAL | TABLET | NDA021892 | b46c0b17-c49b-4791-913f-3e6e1fdbe88e |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 548685889 | OsmoPrep | NDA | Physicians Total Care, Inc. | 2008-05-30 | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | ORAL | TABLET | 656490701 | NDA021892 | 983ce15f-cd37-4f3a-9e51-205860e80976 |
application(s)
| # | id | title | deprecated | applicant | approved | patent | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | ANDA079247 | MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE | True | NOVEL LABORATORIES INC | 2011-12-30 | ANDA079247_001 | |
| 2 | NDA021892 | OSMOPREP | SALIX PHARMACEUTICALS INC | 2006-03-16 | p7687075, SUBSTANCE | NDA021892_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA079247_001 | discontinued | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (0.398GM), SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (1.102GM) | ORAL | TABLET | False | 2011-12-30 | MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE |
| 2 | NDA021892_001 | RX | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (1.102GM), SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (0.398GM) | ORAL | TABLET | True | 2006-03-16 | OSMOPREP |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p7687075 (view patent) | 2028-06-22 | NDA021892 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 983ce15f-cd37-4f3a-9e51-205860e80976 (view SPL) | prescription | Human Prescription | Physicians Total Care, Inc. | relabel, repack | 2010-06-04 | 3 | 548685889 | |
| 2 | b46c0b17-c49b-4791-913f-3e6e1fdbe88e (view SPL) | These highlights do not include all the information needed to useOSMOPREP safely and effectively. See full prescribing information for OSMOPREP. OSMOPREP(sodium phosphate, monobasic, monohydrate, sodium phosphate, dibasic anhydrous)Tablets for oral use Initial U.S. Approval: 2006 | prescription | Human Prescription | Salix Pharmaceuticals, Inc. | 2013-03-27 | 20 | 656490701 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII