Cefoxitin Injectable Solution
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- App Pharmaceuticals, Llc (2015-09-24)
- Oldest Current Product
- 2006-02-13
- License(s)
- ANDA
- RxNORM
- INJECTABLE SOLUTION\CEFOXITIN
- FDAOB
- INJECTION\INJECTION\CEFOXITIN SODIUM\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFOXITIN SODIUM
- SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFOXITIN
product(s) by strength(s)
cefoxitin 200 mg/ml injectable solution
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 001439876 | ANDA | West-Ward Pharmaceutical Corp | 2010-02-26 | CEFOXITIN SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA065239 | 6a4a2afa-4f00-41d4-bd6d-baa0a95f6929 |
| 2 | 250210111 | ANDA | Sagent Pharmaceuticals | 2010-08-12 | CEFOXITIN SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA065415 | 4c6f7665-204f-6c69-7669-61204d756e6e |
| 3 | 445670247 | ANDA | Wg Critical Care, Llc | 2013-10-01 | CEFOXITIN SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA065415 | f5288962-caee-4771-8229-df9cdefcfa67 |
| 4 | 605050761 | ANDA | Apotex Corp | 2006-02-13 | CEFOXITIN SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA065312 | 7ab61c2b-2d17-4a73-aed7-23e72076d11b |
| 5 | 633230343 | ANDA | App Pharmaceuticals, Llc | 2012-02-21 | CEFOXITIN SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA065415 | 7ae80b51-b62d-4adf-be6a-9d320cd97c76 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug | in other drug docs |
|---|---|---|---|---|---|---|---|
| 1 | ANDA062757 | MEFOXIN | True | MYLAN INSTITUTIONAL LLC | 1987-01-08 | ANDA062757_001, ANDA062757_002 | Cefoxitin Injection |
| 2 | ANDA063182 | MEFOXIN IN PLASTIC CONTAINER | MYLAN INSTITUTIONAL LLC | 1993-01-25 | ANDA063182_001, ANDA063182_002 | Cefoxitin Injection | |
| 3 | ANDA065011 | CEFOXITIN | True | FRESENIUS KABI USA LLC | 2000-07-03 | ANDA065011_001 | Cefoxitin Injection |
| 4 | ANDA065012 | CEFOXITIN | True | FRESENIUS KABI USA LLC | 2000-07-03 | ANDA065012_001, ANDA065012_002 | Cefoxitin Injection |
| 5 | ANDA065050 | CEFOXITIN | HIKMA MAPLE LTD | 2000-09-11 | ANDA065050_001 | Cefoxitin Injection | |
| 6 | ANDA065051 | CEFOXITIN | HIKMA MAPLE LTD | 2000-09-11 | ANDA065051_001, ANDA065051_002 | Cefoxitin Injection | |
| 7 | ANDA065214 | CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER | B BRAUN MEDICAL INC | 2006-03-10 | ANDA065214_001, ANDA065214_002 | Cefoxitin Injection | |
| 8 | ANDA065238 | CEFOXITIN | HIKMA FARMACEUTICA (PORTUGAL) SA | 2010-03-12 | ANDA065238_001, ANDA065238_002 | Cefoxitin Injection | |
| 9 | ANDA065239 | CEFOXITIN | HIKMA FARMACEUTICA (PORTUGAL) SA | 2010-03-02 | ANDA065239_001 | Cefoxitin Injection | |
| 10 | ANDA065312 | CEFOXITIN | HOSPIRA INC | 2006-02-13 | ANDA065312_001 | Cefoxitin Injection | |
| 11 | ANDA065313 | CEFOXITIN | HOSPIRA INC | 2006-01-23 | ANDA065313_001, ANDA065313_002 | Cefoxitin Injection | |
| 12 | ANDA065414 | CEFOXITIN | ACS DOBFAR SPA | 2009-06-12 | ANDA065414_001, ANDA065414_002 | Cefoxitin Injection | |
| 13 | ANDA065415 | CEFOXITIN | ACS DOBFAR SPA | 2010-05-19 | ANDA065415_001 | Cefoxitin Injection | |
| 14 | ANDA065464 | CEFOXITIN | ANTIBIOTICOS DO BRASIL LTDA | 2011-08-31 | ANDA065464_001 | Cefoxitin Injection | |
| 15 | ANDA065467 | CEFOXITIN | ANTIBIOTICOS DO BRASIL LTDA | 2011-08-31 | ANDA065467_001, ANDA065467_002 | Cefoxitin Injection | |
| 16 | NDA050517 | MEFOXIN | True | MYLAN INSTITUTIONAL LLC | NDA050517_001, NDA050517_002, NDA050517_003 | Cefoxitin Injection | |
| 17 | NDA050581 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | True | MERCK AND CO INC | 1984-09-20 | NDA050581_001, NDA050581_002, NDA050581_003, NDA050581_004 | Cefoxitin Injection |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA062757_001 | discontinued | CEFOXITIN SODIUM (EQ 1GM BASE/VIAL) | INJECTION | False | 1987-01-08 | MEFOXIN | |
| 2 | ANDA062757_002 | discontinued | CEFOXITIN SODIUM (EQ 2GM BASE/VIAL) | INJECTION | False | 1987-01-08 | MEFOXIN | |
| 3 | ANDA063182_001 | RX | CEFOXITIN SODIUM (EQ 20MG BASE/ML) | INJECTION | True | 1993-01-25 | MEFOXIN IN PLASTIC CONTAINER | |
| 4 | ANDA063182_002 | RX | CEFOXITIN SODIUM (EQ 40MG BASE/ML) | INJECTION | True | 1993-01-25 | MEFOXIN IN PLASTIC CONTAINER | |
| 5 | ANDA065011_001 | discontinued | CEFOXITIN SODIUM (EQ 10GM BASE/VIAL) | INJECTION | False | 2000-07-03 | CEFOXITIN | |
| 6 | ANDA065012_001 | discontinued | CEFOXITIN SODIUM (EQ 1GM BASE/VIAL) | INJECTION | False | 2000-07-03 | CEFOXITIN | |
| 7 | ANDA065012_002 | discontinued | CEFOXITIN SODIUM (EQ 2GM BASE/VIAL) | INJECTION | False | 2000-07-03 | CEFOXITIN | |
| 8 | ANDA065050_001 | RX | CEFOXITIN SODIUM (EQ 10GM BASE/VIAL) | INJECTION | False | AP | 2000-09-11 | CEFOXITIN |
| 9 | ANDA065051_001 | RX | CEFOXITIN SODIUM (EQ 1GM BASE/VIAL) | INJECTION | False | AP | 2000-09-11 | CEFOXITIN |
| 10 | ANDA065051_002 | RX | CEFOXITIN SODIUM (EQ 2GM BASE/VIAL) | INJECTION | False | AP | 2000-09-11 | CEFOXITIN |
| 11 | ANDA065214_001 | RX | CEFOXITIN SODIUM (EQ 1GM BASE/VIAL) | INJECTION | False | AP | 2006-03-10 | CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER |
| 12 | ANDA065214_002 | RX | CEFOXITIN SODIUM (EQ 2GM BASE/VIAL) | INJECTION | False | AP | 2006-03-10 | CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER |
| 13 | ANDA065238_001 | RX | CEFOXITIN SODIUM (EQ 1GM BASE/VIAL) | INJECTION | False | AP | 2010-03-12 | CEFOXITIN |
| 14 | ANDA065238_002 | RX | CEFOXITIN SODIUM (EQ 2GM BASE/VIAL) | INJECTION | False | AP | 2010-03-12 | CEFOXITIN |
| 15 | ANDA065239_001 | RX | CEFOXITIN SODIUM (EQ 10GM BASE/VIAL) | INJECTION | False | AP | 2010-03-02 | CEFOXITIN |
| 16 | ANDA065312_001 | RX | CEFOXITIN SODIUM (EQ 10GM BASE/VIAL) | INJECTION | False | AP | 2006-02-13 | CEFOXITIN |
| 17 | ANDA065313_001 | RX | CEFOXITIN SODIUM (EQ 1GM BASE/VIAL) | INJECTION | False | AP | 2006-01-23 | CEFOXITIN |
| 18 | ANDA065313_002 | RX | CEFOXITIN SODIUM (EQ 2GM BASE/VIAL) | INJECTION | False | AP | 2006-01-23 | CEFOXITIN |
| 19 | ANDA065414_001 | RX | CEFOXITIN SODIUM (EQ 1GM BASE/VIAL) | INJECTION | True | AP | 2009-06-12 | CEFOXITIN |
| 20 | ANDA065414_002 | RX | CEFOXITIN SODIUM (EQ 2GM BASE/VIAL) | INJECTION | True | AP | 2009-06-12 | CEFOXITIN |
| 21 | ANDA065415_001 | RX | CEFOXITIN SODIUM (EQ 10GM BASE/VIAL) | INJECTION | True | AP | 2010-05-19 | CEFOXITIN |
| 22 | ANDA065464_001 | RX | CEFOXITIN SODIUM (EQ 10GM BASE/VIAL) | INJECTION | False | AP | 2011-08-31 | CEFOXITIN |
| 23 | ANDA065467_001 | RX | CEFOXITIN SODIUM (EQ 1GM BASE/VIAL) | INJECTION | False | AP | 2011-08-31 | CEFOXITIN |
| 24 | ANDA065467_002 | RX | CEFOXITIN SODIUM (EQ 2GM BASE/VIAL) | INJECTION | False | AP | 2011-08-31 | CEFOXITIN |
| 25 | NDA050517_001 | discontinued | CEFOXITIN SODIUM (EQ 1GM BASE/VIAL) | INJECTION | False | MEFOXIN | ||
| 26 | NDA050517_002 | discontinued | CEFOXITIN SODIUM (EQ 2GM BASE/VIAL) | INJECTION | False | MEFOXIN | ||
| 27 | NDA050517_003 | discontinued | CEFOXITIN SODIUM (EQ 10GM BASE/VIAL) | INJECTION | False | MEFOXIN | ||
| 28 | NDA050581_001 | discontinued | CEFOXITIN SODIUM (EQ 40MG BASE/ML) | INJECTION | False | 1984-09-20 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | |
| 29 | NDA050581_002 | discontinued | CEFOXITIN SODIUM (EQ 20MG BASE/ML) | INJECTION | False | 1984-09-20 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | |
| 30 | NDA050581_003 | discontinued | CEFOXITIN SODIUM (EQ 20MG BASE/ML) | INJECTION | False | 1984-09-20 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | |
| 31 | NDA050581_004 | discontinued | CEFOXITIN SODIUM (EQ 40MG BASE/ML) | INJECTION | False | 1984-09-20 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 4c6f7665-204f-6c69-7669-61204d756e6e (view SPL) | CEFOXITIN FOR INJECTION, USP | prescription | Human Prescription | Sagent Pharmaceuticals | 2015-07-16 | 2 | 250210111 | |
| 2 | 6a4a2afa-4f00-41d4-bd6d-baa0a95f6929 (view SPL) | CEFOXITIN FOR INJECTION, USP PHARMACY BULK PACKAGENOT FOR DIRECT INFUSION | prescription | Human Prescription | West-Ward Pharmaceutical Corp | MANUFACTURE | 2010-03-15 | 2 | 001439876 |
| 3 | 7ab61c2b-2d17-4a73-aed7-23e72076d11b (view SPL) | CEFOXITIN FOR INJECTION, USP | prescription | Human Prescription | Apotex Corp | 2013-03-29 | 11 | 605050761 | |
| 4 | 7ae80b51-b62d-4adf-be6a-9d320cd97c76 (view SPL) | Cefoxitin for Injection USP | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2015-09-24 | 3 | 633230343 |
| 5 | f5288962-caee-4771-8229-df9cdefcfa67 (view SPL) | Cefoxitin for Injection, USP | prescription | Human Prescription | Wg Critical Care, Llc | 2015-02-19 | 1 | 445670247 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII