fosphenytoin Injection
- Brand(s)
- Cerebyx
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- App Pharmaceuticals, Llc (2015-04-15)
- Oldest Current Product
- 2007-08-06
- License(s)
- NDA, ANDA
- RxNORM
- INJECTION\FOSPHENYTOIN
- FDAOB
- INJECTION\INJECTION\FOSPHENYTOIN SODIUM\rdfq
- SPL Active
- INTRAMUSCULAR\INJECTION, SOLUTION\FOSPHENYTOIN SODIUM
INTRAMUSCULAR\INJECTION\FOSPHENYTOIN SODIUM
INTRAVENOUS\INJECTION, SOLUTION\FOSPHENYTOIN SODIUM - SPL Moiety
- INTRAMUSCULAR\INJECTION, SOLUTION\FOSPHENYTOIN
INTRAMUSCULAR\INJECTION, SOLUTION\PHENYTOIN
INTRAMUSCULAR\INJECTION\PHENYTOIN
INTRAVENOUS\INJECTION, SOLUTION\PHENYTOIN
product(s) by strength(s)
fosphenytoin sodium 75 mg/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000696001 | Cerebyx | NDA | Pfizer Labs | 2013-10-28 | FOSPHENYTOIN SODIUM | INTRAVENOUS | INJECTION, SOLUTION | NDA020450 | d4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 004094857 | ANDA | Hospira, Inc. | 2007-08-06 | FOSPHENYTOIN SODIUM | INTRAVENOUS | INJECTION, SOLUTION | ANDA078158 | ce76cbd9-1b1b-4944-28a8-39acfb01eb1d |
| 2 | 101390025 | ANDA | Generamedix Inc. | 2007-08-06 | FOSPHENYTOIN SODIUM | INTRAVENOUS | INJECTION, SOLUTION | ANDA078277 | 6f42f3bb-a8ee-438c-84c6-5f803753ce70 |
| 3 | 633230403 | ANDA | App Pharmaceuticals, Llc | 2009-12-14 | FOSPHENYTOIN SODIUM | INTRAVENOUS | INJECTION, SOLUTION | ANDA078052 | a9f7e7fd-7ca2-47ac-8856-999e110e2b9a, b60c9c82-e5c7-4e05-98c7-5bbba4af04b2 |
2 ml fosphenytoin sodium 75 mg/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000695471 | Cerebyx | NDA | Pfizer Labs | 2013-10-28 | FOSPHENYTOIN SODIUM | INTRAMUSCULAR | INJECTION, SOLUTION | NDA020450 | de5a6711-4abb-4c3d-a18b-266b094ace11 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 001439788 | ANDA | West-Ward Pharmaceutical Corp | 2009-12-02 | FOSPHENYTOIN SODIUM | INTRAMUSCULAR | INJECTION, SOLUTION | ANDA078765 | c92df63b-5140-4213-8d43-8327ff6230b7 |
| 2 | 005176902 | ANDA | American Regent, Inc. | 2010-07-30 | FOSPHENYTOIN SODIUM | INTRAMUSCULAR | INJECTION, SOLUTION | ANDA090099 | 24028dc7-6cd9-4a7b-ac21-77e47ddef17c |
| 3 | 006416136 | ANDA | West-Ward Pharmaceuticals Corp. | 2007-08-06 | FOSPHENYTOIN SODIUM | INTRAMUSCULAR | INJECTION | ANDA077989 | 519a44e3-8a93-456c-b71c-894513810d45 |
| 4 | 473350833 | ANDA | Sun Pharma Global Fze | 2009-08-14 | FOSPHENYTOIN SODIUM | INTRAMUSCULAR | INJECTION, SOLUTION | ANDA078417 | 3f6b53fb-8ce9-4897-ae13-52a8a451d48c |
| 5 | 651620998 | ANDA | Amneal Pharmaceuticals | 2013-05-17 | FOSPHENYTOIN SODIUM | INTRAMUSCULAR | INJECTION | ANDA078476 | 87ff8a91-5b37-401c-b75c-dc6efd348761 |
10 ml fosphenytoin sodium 75 mg/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000695474 | Cerebyx | NDA | Pfizer Labs | 2013-10-28 | FOSPHENYTOIN SODIUM | INTRAMUSCULAR | INJECTION, SOLUTION | NDA020450 | de5a6711-4abb-4c3d-a18b-266b094ace11 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 001439782 | ANDA | West-Ward Pharmaceutical Corp | 2009-12-02 | FOSPHENYTOIN SODIUM | INTRAMUSCULAR | INJECTION, SOLUTION | ANDA078765 | c92df63b-5140-4213-8d43-8327ff6230b7 |
| 2 | 006416137 | ANDA | West-Ward Pharmaceuticals Corp. | 2007-08-06 | FOSPHENYTOIN SODIUM | INTRAMUSCULAR | INJECTION | ANDA077989 | 519a44e3-8a93-456c-b71c-894513810d45 |
| 3 | 473350834 | ANDA | Sun Pharma Global Fze | 2009-08-14 | FOSPHENYTOIN SODIUM | INTRAMUSCULAR | INJECTION, SOLUTION | ANDA078417 | 3f6b53fb-8ce9-4897-ae13-52a8a451d48c |
| 4 | 651620999 | ANDA | Amneal Pharmaceuticals | 2013-05-17 | FOSPHENYTOIN SODIUM | INTRAMUSCULAR | INJECTION | ANDA078476 | 87ff8a91-5b37-401c-b75c-dc6efd348761 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA076886 | FOSPHENYTOIN SODIUM | True | TEVA PHARMACEUTICALS USA | 2007-08-06 | ANDA076886_001 |
| 2 | ANDA077481 | FOSPHENYTOIN SODIUM | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | 2007-08-06 | ANDA077481_001 | |
| 3 | ANDA077989 | FOSPHENYTOIN SODIUM | HIKMA MAPLE LTD | 2007-08-06 | ANDA077989_001 | |
| 4 | ANDA078052 | FOSPHENYTOIN SODIUM | FRESENIUS KABI USA LLC | 2007-08-06 | ANDA078052_001 | |
| 5 | ANDA078126 | FOSPHENYTOIN SODIUM | True | APOTEX INC | 2007-08-06 | ANDA078126_001 |
| 6 | ANDA078137 | FOSPHENYTOIN SODIUM | WOCKHARDT LTD | 2007-08-06 | ANDA078137_001 | |
| 7 | ANDA078158 | FOSPHENYTOIN SODIUM | HOSPIRA INC | 2007-08-06 | ANDA078158_001 | |
| 8 | ANDA078277 | FOSPHENYTOIN SODIUM | LUITPOLD PHARMACEUTICALS INC | 2007-08-06 | ANDA078277_001 | |
| 9 | ANDA078417 | FOSPHENYTOIN SODIUM | SUN PHARMA GLOBAL INC | 2008-03-18 | ANDA078417_001 | |
| 10 | ANDA078476 | FOSPHENYTOIN SODIUM | AMNEAL PHARMACEUTICALS CO GMBH | 2008-03-18 | ANDA078476_001 | |
| 11 | ANDA078736 | FOSPHENYTOIN SODIUM | MYLAN LABORATORIES LTD | 2010-06-08 | ANDA078736_001 | |
| 12 | ANDA078765 | FOSPHENYTOIN SODIUM | HIKMA FARMACEUTICA (PORTUGAL) SA | 2009-12-02 | ANDA078765_001 | |
| 13 | ANDA090099 | FOSPHENYTOIN SODIUM | LUITPOLD PHARMACEUTICALS INC | 2010-05-13 | ANDA090099_001 | |
| 14 | NDA020450 | CEREBYX | PARKE DAVIS DIV WARNER LAMBERT CO | 1996-08-05 | NDA020450_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA076886_001 | discontinued | FOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML) | INJECTION | False | 2007-08-06 | FOSPHENYTOIN SODIUM | |
| 2 | ANDA077481_001 | RX | FOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML) | INJECTION | False | AP | 2007-08-06 | FOSPHENYTOIN SODIUM |
| 3 | ANDA077989_001 | RX | FOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML) | INJECTION | False | AP | 2007-08-06 | FOSPHENYTOIN SODIUM |
| 4 | ANDA078052_001 | RX | FOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML) | INJECTION | True | AP | 2007-08-06 | FOSPHENYTOIN SODIUM |
| 5 | ANDA078126_001 | discontinued | FOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML) | INJECTION | False | 2007-08-06 | FOSPHENYTOIN SODIUM | |
| 6 | ANDA078137_001 | RX | FOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML) | INJECTION | False | AP | 2007-08-06 | FOSPHENYTOIN SODIUM |
| 7 | ANDA078158_001 | RX | FOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML) | INJECTION | False | AP | 2007-08-06 | FOSPHENYTOIN SODIUM |
| 8 | ANDA078277_001 | RX | FOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML) | INJECTION | False | AP | 2007-08-06 | FOSPHENYTOIN SODIUM |
| 9 | ANDA078417_001 | RX | FOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML) | INJECTION | False | AP | 2008-03-18 | FOSPHENYTOIN SODIUM |
| 10 | ANDA078476_001 | RX | FOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML) | INJECTION | False | AP | 2008-03-18 | FOSPHENYTOIN SODIUM |
| 11 | ANDA078736_001 | RX | FOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML) | INJECTION | False | AP | 2010-06-08 | FOSPHENYTOIN SODIUM |
| 12 | ANDA078765_001 | RX | FOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML) | INJECTION | False | AP | 2009-12-02 | FOSPHENYTOIN SODIUM |
| 13 | ANDA090099_001 | RX | FOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML) | INJECTION | False | AP | 2010-05-13 | FOSPHENYTOIN SODIUM |
| 14 | NDA020450_001 | RX | FOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML) | INJECTION | False | AP | 1996-08-05 | CEREBYX |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 24028dc7-6cd9-4a7b-ac21-77e47ddef17c (view SPL) | FOSPHENYTOIN SODIUM INJECTION USP | prescription | Human Prescription | American Regent, Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE | 2010-05-27 | 4 | 005176902 |
| 2 | 3f6b53fb-8ce9-4897-ae13-52a8a451d48c (view SPL) | Fosphenytoin Sodium Injection USP | prescription | Human Prescription | Sun Pharma Global Fze | analysis, manufacture | 2009-08-06 | 1 | 473350833, 473350834 |
| 3 | 519a44e3-8a93-456c-b71c-894513810d45 (view SPL) | Fosphenytoin Sodium Injection, USP | prescription | Human Prescription | West-Ward Pharmaceuticals Corp. | ANALYSIS, LABEL, MANUFACTURE | 2015-06-11 | 9 | 006416136, 006416137 |
| 4 | 6f42f3bb-a8ee-438c-84c6-5f803753ce70 (view SPL) | FOSPHENYTOIN SODIUM INJECTION USP | prescription | Human Prescription | Generamedix Inc. | ANALYSIS, MANUFACTURE | 2014-08-29 | 2 | 101390025 |
| 5 | 87ff8a91-5b37-401c-b75c-dc6efd348761 (view SPL) | Fosphenytoin Sodium Injection, USP Rx Only | prescription | Human Prescription | Amneal Pharmaceuticals | ANALYSIS, MANUFACTURE, PACK | 2015-06-26 | 11 | 651620998, 651620999 |
| 6 | a9f7e7fd-7ca2-47ac-8856-999e110e2b9a (view SPL) | Fosphenytoin Sodium Injection USP | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2014-04-03 | 1 | 633230403 |
| 7 | b60c9c82-e5c7-4e05-98c7-5bbba4af04b2 (view SPL) | Fosphenytoin Sodium Injection USP | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2015-04-15 | 6 | 633230403 |
| 8 | c92df63b-5140-4213-8d43-8327ff6230b7 (view SPL) | Fosphenytoin Sodium Injection, USP | prescription | Human Prescription | West-Ward Pharmaceutical Corp | ANALYSIS, LABEL, MANUFACTURE, PACK | 2014-09-15 | 7 | 001439782, 001439788 |
| 9 | ce76cbd9-1b1b-4944-28a8-39acfb01eb1d (view SPL) | Fosphenytoin SodiumInjection, USP | prescription | Human Prescription | Hospira, Inc. | 2013-08-29 | 4 | 004094857 | |
| 10 | d4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a (view SPL) | CEREBYX (Fosphenytoin Sodium Injection) | prescription | Human Prescription | Pfizer Labs | MANUFACTURE | 2015-06-11 | 8 | 000696001 |
| 11 | de5a6711-4abb-4c3d-a18b-266b094ace11 (view SPL) | CEREBYX(Fosphenytoin Sodium Injection) | prescription | Human Prescription | Pfizer Labs | ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK | 2015-07-06 | 2 | 000695471, 000695474 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII