Application 050578
- Type
- NDA
- Sponsor
- TELIGENT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FORTAZ | CEFTAZIDIME | INJECTABLE;INJECTION | 500MG/VIAL | Yes | Yes |
| 002 | FORTAZ | CEFTAZIDIME | INJECTABLE;INJECTION | 1GM/VIAL | Yes | Yes |
| 003 | FORTAZ | CEFTAZIDIME | INJECTABLE;INJECTION | 2GM/VIAL | Yes | Yes |
| 004 | FORTAZ | CEFTAZIDIME | INJECTABLE;INJECTION | 6GM/VIAL | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050578-001 | FORTAZ | CEFTAZIDIME | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | |
| N050578-002 | FORTAZ | CEFTAZIDIME | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | |
| N050578-003 | FORTAZ | CEFTAZIDIME | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | |
| N050578-004 | FORTAZ | CEFTAZIDIME | 6GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N050578-001 | FORTAZ | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N050578-002 | FORTAZ | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N050578-003 | FORTAZ | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N050578-004 | FORTAZ | 6GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N050578-001 | FORTAZ | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050578-002 | FORTAZ | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050578-003 | FORTAZ | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050578-004 | FORTAZ | 6GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N050578-001 | FORTAZ | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050578-002 | FORTAZ | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050578-003 | FORTAZ | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050578-004 | FORTAZ | 6GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050578-001 | FORTAZ | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050578-002 | FORTAZ | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050578-003 | FORTAZ | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050578-004 | FORTAZ | 6GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050578-001 | FORTAZ | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050578-002 | FORTAZ | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050578-003 | FORTAZ | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050578-004 | FORTAZ | 6GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050578-001 | FORTAZ | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050578-002 | FORTAZ | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050578-003 | FORTAZ | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050578-004 | FORTAZ | 6GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050578-001 | FORTAZ | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050578-002 | FORTAZ | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050578-003 | FORTAZ | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050578-004 | FORTAZ | 6GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050578-001 | FORTAZ | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050578-002 | FORTAZ | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050578-003 | FORTAZ | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050578-004 | FORTAZ | 6GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050578-001 | FORTAZ | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050578-002 | FORTAZ | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050578-003 | FORTAZ | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050578-004 | FORTAZ | 6GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050578-001 | FORTAZ | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050578-002 | FORTAZ | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050578-003 | FORTAZ | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050578-004 | FORTAZ | 6GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-07-19 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-14 00:12 UTC | 2019-12 | N050578-001 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N050578-002 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N050578-003 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N050578-004 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N050578-001 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N050578-002 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N050578-003 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N050578-004 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N050578-001 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N050578-002 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N050578-003 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N050578-004 | AP | 1 | ea99ee380514… |
| 2023-05-13 08:27 UTC | 2023-05 | N050578-001 | AP | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | N050578-002 | AP | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | N050578-003 | AP | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | N050578-004 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N050578-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N050578-002 | AP | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N050578-003 | AP | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N050578-004 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050578-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050578-002 | AP | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050578-003 | AP | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050578-004 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N050578-001 | AP | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N050578-002 | AP | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N050578-003 | AP | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N050578-004 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N050578-001 | AP | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N050578-002 | AP | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N050578-003 | AP | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N050578-004 | AP | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N050578-001 | AP | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N050578-002 | AP | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N050578-003 | AP | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N050578-004 | AP | 1 | cb3db0bc1861… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ceftazidime | CEFTAZIDIME | Sagent Pharmaceuticals | 112c5457-8d71-49f5-b531-9761d7d38c93 | 2026-08-03 | Warnings, Adverse reactions | CEFTAZIDIME |
| TAZICEF | CEFTAZIDIME | Hospira, Inc. | 40d48c5d-650e-461b-a67b-7e65772d1b92 | 2026-05-04 | Warnings, Adverse reactions | CEFTAZIDIME |
| TAZICEF | CEFTAZIDIME | Hospira, Inc. | 1ab5ae3e-e303-4499-4c89-472d7cc1e46c | 2024-07-04 | Warnings, Adverse reactions | CEFTAZIDIME |
| Ceftazidime | CEFTAZIDIME | Sagent Pharmaceuticals | aec64360-8452-4987-a366-a5a4f8762ab6 | 2024-01-03 | Warnings, Adverse reactions | CEFTAZIDIME |
| Ceftazidime | CEFTAZIDIME | WG Critical Care, LLC | bcc81df2-20e3-4738-bfcf-301da883c1d9 | 2023-09-11 | Warnings, Adverse reactions | CEFTAZIDIME |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52565-105 | FORTAZ | ceftazidime | Teligent Pharma, Inc. | NDA | Current |
| 52565-105 | FORTAZ | ceftazidime | Teligent Pharma, Inc. | NDA | Current |
| 52565-106 | FORTAZ | ceftazidime | Teligent Pharma, Inc. | NDA | Current |
| 52565-106 | FORTAZ | ceftazidime | Teligent Pharma, Inc. | NDA | Current |
| 52565-107 | FORTAZ | ceftazidime | Teligent Pharma, Inc. | NDA | Current |
| 52565-107 | FORTAZ | ceftazidime | Teligent Pharma, Inc. | NDA | Current |
| 52565-109 | FORTAZ | ceftazidime | Teligent Pharma, Inc. | NDA | Current |
| 52565-109 | FORTAZ | ceftazidime | Teligent Pharma, Inc. | NDA | Current |
| 52565-110 | FORTAZ | ceftazidime | Teligent Pharma, Inc. | NDA | Current |
| 52565-111 | FORTAZ | ceftazidime | Teligent Pharma, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 61881 | SUPPL | 2020-02-13 |
| 61880 | SUPPL | 2020-02-13 |
| 61872 | SUPPL | 2020-02-12 |
| 61870 | SUPPL | 2020-02-12 |
| 57689 | ORIG | 2019-02-15 |
| 49190 | SUPPL | 2017-08-02 |
| 49161 | SUPPL | 2017-07-31 |
| 30108 | SUPPL | 2014-09-26 |
| 17894 | SUPPL | 2014-09-26 |
| 7837 | SUPPL | 2007-07-16 |
| 17893 | SUPPL | 2007-07-10 |
| 38998 | SUPPL | 2007-03-15 |
| 38997 | SUPPL | 2004-05-27 |
| 30107 | SUPPL | 2004-05-26 |
| 17892 | SUPPL | 2002-03-29 |
| 7836 | SUPPL | 2002-03-29 |
| 30106 | SUPPL | 2002-03-22 |