Ceftazidime Injectable Solution
- Brand(s)
- Fortaz, Tazicef
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Sandoz Inc (2015-07-28)
- Oldest Current Product
- 1986-03-06
- License(s)
- ANDA
- RxNORM
- INJECTABLE SOLUTION\CEFTAZIDIME
- FDAOB
- INJECTION\INJECTION\CEFTAZIDIME\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFTAZIDIME
- SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFTAZIDIME ANHYDROUS
product(s) by strength(s)
ceftazidime 200 mg/ml injectable solution
original product(s)(s)
| # | id | labeler | active ingredient(s) | route | dose form | spl |
|---|---|---|---|---|---|---|
| 1 | 007813179 | Sandoz Inc | CEFTAZIDIME | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | a32a9a03-03ac-45f2-8af5-f5481020144f |
generic product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 004095086 | Tazicef | ANDA | Hospira, Inc. | 1986-03-06 | CEFTAZIDIME | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA062662 | 1ab5ae3e-e303-4499-4c89-472d7cc1e46c |
| 2 | 250210129 | ANDA | Sagent Pharmaceuticals | 2008-05-15, 2015-07-01 | CEFTAZIDIME | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA062640 | 6e454496-f924-4e04-bbeb-1c1fee7082cd, aec64360-8452-4987-a366-a5a4f8762ab6 | |
| 3 | 445670237 | ANDA | Wg Critical Care, Llc | 2013-01-31 | CEFTAZIDIME | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA062640 | 22d6534c-4488-48a1-8d78-e2fb908259de |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug | in other drug docs |
|---|---|---|---|---|---|---|---|
| 1 | ANDA062640 | CEFTAZIDIME | ACS DOBFAR SPA | 1985-11-20 | ANDA062640_001, ANDA062640_002, ANDA062640_003, ANDA062640_004 | Ceftazidime Injection | |
| 2 | ANDA062655 | TAZIDIME | True | ELI LILLY AND CO | 1985-11-20 | ANDA062655_001, ANDA062655_002 | Ceftazidime Injection |
| 3 | ANDA062662 | TAZICEF | HOSPIRA INC | 1986-03-06 | ANDA062662_001, ANDA062662_002, ANDA062662_003, ANDA062662_004 | Ceftazidime Injection | |
| 4 | ANDA062739 | TAZIDIME IN PLASTIC CONTAINER | True | ELI LILLY AND CO | 1986-07-10 | ANDA062739_001, ANDA062739_002 | Ceftazidime Injection |
| 5 | ANDA063322 | PENTACEF | True | GLAXOSMITHKLINE | 1995-11-07 | ANDA063322_001, ANDA063322_002 | Ceftazidime Injection |
| 6 | ANDA064006 | PENTACEF | True | GLAXOSMITHKLINE | 1992-03-31 | ANDA064006_001, ANDA064006_002 | Ceftazidime Injection |
| 7 | ANDA064008 | PENTACEF | True | GLAXOSMITHKLINE | 1992-03-31 | ANDA064008_001, ANDA064008_002 | Ceftazidime Injection |
| 8 | ANDA064032 | TAZICEF | HOSPIRA INC | 1993-10-31 | ANDA064032_001, ANDA064032_002 | Ceftazidime Injection | |
| 9 | ANDA065196 | CEFTAZIDIME | WOCKHARDT LTD | 2008-10-15 | ANDA065196_001 | Ceftazidime Injection | |
| 10 | ANDA065481 | CEFTAZIDIME | True | AUROBINDO PHARMA LTD | 2010-05-28 | ANDA065481_001, ANDA065481_002, ANDA065481_003 | Ceftazidime Injection |
| 11 | ANDA065482 | CEFTAZIDIME | True | AUROBINDO PHARMA LTD | 2010-05-28 | ANDA065482_001 | Ceftazidime Injection |
| 12 | NDA050578 | FORTAZ | IGI LABORATORIES INC | 1985-07-19 | NDA050578_001, NDA050578_002, NDA050578_003, NDA050578_004 | Ceftazidime Injection | |
| 13 | NDA050646 | CEPTAZ | True | GLAXOSMITHKLINE | 1990-09-27 | NDA050646_001, NDA050646_002, NDA050646_003, NDA050646_004 | Ceftazidime Injection |
| 14 | NDA050823 | CEFTAZIDIME IN DEXTROSE CONTAINER | B BRAUN MEDICAL INC | 2011-06-13 | NDA050823_001, NDA050823_002 | Ceftazidime Injection |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA062640_001 | RX | CEFTAZIDIME (500MG/VIAL) | INJECTION | False | AP | 1985-11-20 | CEFTAZIDIME |
| 2 | ANDA062640_002 | RX | CEFTAZIDIME (1GM/VIAL) | INJECTION | False | AP | 1985-11-20 | CEFTAZIDIME |
| 3 | ANDA062640_003 | RX | CEFTAZIDIME (2GM/VIAL) | INJECTION | False | AP | 1985-11-20 | CEFTAZIDIME |
| 4 | ANDA062640_004 | RX | CEFTAZIDIME (6GM/VIAL) | INJECTION | False | AP | 1992-02-03 | CEFTAZIDIME |
| 5 | ANDA062655_001 | discontinued | CEFTAZIDIME (1GM/VIAL) | INJECTION | False | 1985-11-20 | TAZIDIME | |
| 6 | ANDA062655_002 | discontinued | CEFTAZIDIME (2GM/VIAL) | INJECTION | False | 1985-11-20 | TAZIDIME | |
| 7 | ANDA062662_001 | RX | CEFTAZIDIME (500MG/VIAL) | INJECTION | False | AP | 1986-03-06 | TAZICEF |
| 8 | ANDA062662_002 | RX | CEFTAZIDIME (1GM/VIAL) | INJECTION | False | AP | 1986-03-06 | TAZICEF |
| 9 | ANDA062662_003 | RX | CEFTAZIDIME (2GM/VIAL) | INJECTION | False | AP | 1986-03-06 | TAZICEF |
| 10 | ANDA062662_004 | RX | CEFTAZIDIME (6GM/VIAL) | INJECTION | False | AP | 1986-03-06 | TAZICEF |
| 11 | ANDA062739_001 | discontinued | CEFTAZIDIME (1GM/VIAL) | INJECTION | False | 1986-07-10 | TAZIDIME IN PLASTIC CONTAINER | |
| 12 | ANDA062739_002 | discontinued | CEFTAZIDIME (2GM/VIAL) | INJECTION | False | 1986-07-10 | TAZIDIME IN PLASTIC CONTAINER | |
| 13 | ANDA063322_001 | discontinued | CEFTAZIDIME (1GM/VIAL) | INJECTION | False | 1995-11-07 | PENTACEF | |
| 14 | ANDA063322_002 | discontinued | CEFTAZIDIME (2GM/VIAL) | INJECTION | False | 1995-11-07 | PENTACEF | |
| 15 | ANDA064006_001 | discontinued | CEFTAZIDIME (1GM/VIAL) | INJECTION | False | 1992-03-31 | PENTACEF | |
| 16 | ANDA064006_002 | discontinued | CEFTAZIDIME (2GM/VIAL) | INJECTION | False | 1992-03-31 | PENTACEF | |
| 17 | ANDA064008_001 | discontinued | CEFTAZIDIME (6GM/VIAL) | INJECTION | False | 1992-03-31 | PENTACEF | |
| 18 | ANDA064008_002 | discontinued | CEFTAZIDIME (10GM/VIAL) | INJECTION | False | 1992-03-31 | PENTACEF | |
| 19 | ANDA064032_001 | RX | CEFTAZIDIME (1GM/VIAL) | INJECTION | False | AP | 1993-10-31 | TAZICEF |
| 20 | ANDA064032_002 | RX | CEFTAZIDIME (2GM/VIAL) | INJECTION | False | AP | 1993-10-31 | TAZICEF |
| 21 | ANDA065196_001 | RX | CEFTAZIDIME (1GM/VIAL) | INJECTION | False | AP | 2008-10-15 | CEFTAZIDIME |
| 22 | ANDA065481_001 | discontinued | CEFTAZIDIME (500MG/VIAL) | INJECTION | False | 2010-05-28 | CEFTAZIDIME | |
| 23 | ANDA065481_002 | discontinued | CEFTAZIDIME (1GM/VIAL) | INJECTION | False | 2010-05-28 | CEFTAZIDIME | |
| 24 | ANDA065481_003 | discontinued | CEFTAZIDIME (2GM/VIAL) | INJECTION | False | 2010-05-28 | CEFTAZIDIME | |
| 25 | ANDA065482_001 | discontinued | CEFTAZIDIME (6GM/VIAL) | INJECTION | False | 2010-05-28 | CEFTAZIDIME | |
| 26 | NDA050578_001 | RX | CEFTAZIDIME (500MG/VIAL) | INJECTION | True | AP | 1985-07-19 | FORTAZ |
| 27 | NDA050578_002 | RX | CEFTAZIDIME (1GM/VIAL) | INJECTION | True | AP | 1985-07-19 | FORTAZ |
| 28 | NDA050578_003 | RX | CEFTAZIDIME (2GM/VIAL) | INJECTION | True | AP | 1985-07-19 | FORTAZ |
| 29 | NDA050578_004 | RX | CEFTAZIDIME (6GM/VIAL) | INJECTION | True | AP | 1985-07-19 | FORTAZ |
| 30 | NDA050646_001 | discontinued | CEFTAZIDIME (500MG/VIAL) | INJECTION | False | 1990-09-27 | CEPTAZ | |
| 31 | NDA050646_002 | discontinued | CEFTAZIDIME (1GM/VIAL) | INJECTION | False | 1990-09-27 | CEPTAZ | |
| 32 | NDA050646_003 | discontinued | CEFTAZIDIME (2GM/VIAL) | INJECTION | False | 1990-09-27 | CEPTAZ | |
| 33 | NDA050646_004 | discontinued | CEFTAZIDIME (10GM/VIAL) | INJECTION | False | 1990-09-27 | CEPTAZ | |
| 34 | NDA050823_001 | RX | CEFTAZIDIME (EQ 1GM BASE) | INJECTION | False | 2011-06-13 | CEFTAZIDIME IN DEXTROSE CONTAINER | |
| 35 | NDA050823_002 | RX | CEFTAZIDIME (EQ 2GM BASE) | INJECTION | True | 2011-06-13 | CEFTAZIDIME IN DEXTROSE CONTAINER |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 1ab5ae3e-e303-4499-4c89-472d7cc1e46c (view SPL) | PRESCRIBING INFORMATION TAZICEFRx only brand of ceftazidime for injection, USP | prescription | Human Prescription | Hospira, Inc. | 2014-10-27 | 13 | 004095086 | ||
| 2 | 22d6534c-4488-48a1-8d78-e2fb908259de (view SPL) | Ceftazidime for Injection | prescription | Human Prescription | Wg Critical Care, Llc | 2013-01-19 | 2 | 445670237 | ||
| 3 | 6e454496-f924-4e04-bbeb-1c1fee7082cd (view SPL) | Ceftazidime for Injection, USP | prescription | Human Prescription | Sagent Pharmaceuticals | 2015-03-13 | 2 | 250210129 | ||
| 4 | 981b9abe-4c76-41b2-8f36-eb3e28fa5adc (view SPL) | FORTAZ (ceftazidime for injection)FORTAZ (ceftazidime injection) | prescription | Human Prescription | Covis Pharmaceuticals, Inc. | MANUFACTURE, PACK | 2014-10-08 | 5 | 249870377, 249870378, 249870379, 249870382, 249870412, 249870413, 249870434, 249870435 | Ceftazidime Injection |
| 5 | a32a9a03-03ac-45f2-8af5-f5481020144f (view SPL) | Ceftazidime for Injection, USP | prescription | Human Prescription | Sandoz Inc | 2015-07-28 | 12 | 007813179 | ||
| 6 | aec64360-8452-4987-a366-a5a4f8762ab6 (view SPL) | Ceftazidime for Injection, USP | prescription | Human Prescription | Sagent Pharmaceuticals | 2015-01-08 | 4 | 250210129 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII