Application 090375
- Type
- ANDA
- Sponsor
- HOSPIRA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | No | No |
| 002 | AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090375-001 | AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | ||
| A090375-002 | AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090375-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090375-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090375-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090375-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090375-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090375-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090375-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090375-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090375-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090375-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090375-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090375-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090375-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090375-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090375-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090375-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090375-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090375-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090375-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090375-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090375-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090375-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090375-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090375-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090375-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090375-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090375-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090375-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090375-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090375-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090375-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090375-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090375-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090375-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090375-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090375-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090375-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090375-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090375-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090375-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-12-21 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-09-15 20:21 UTC | 2019-09 | A090375-001 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A090375-002 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090375-001 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A090375-002 | AP | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Ampicillin and Sulbactam | AMPICILLIN SODIUM AND SULBACTAM SODIUM | Meitheal Pharmaceuticals Inc. | 139b4b2e-46f7-44a8-9cc1-774afa463b80 | 2026-07-23 | Warnings, Adverse reactions | Ampicillin and Sulbactam |
| Ampicillin and Sulbactam | AMPICILLIN SODIUM AND SULBACTAM SODIUM | Meitheal Pharmaceuticals Inc. | 006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d | 2026-07-22 | Warnings, Adverse reactions | Ampicillin and Sulbactam |
| ampicillin and sulbactam | AMPICILLIN AND SULBACTAM | Sagent Pharmaceuticals | a67ae347-487d-4751-a841-b321e81db26f | 2026-07-21 | Warnings, Adverse reactions | ampicillin and sulbactam |
| Ampicillin and Sulbactam | AMPICILLIN AND SULBACTAM | WG Critical Care, LLC | 72a37674-8cb2-4b40-aac8-d345ffcf22f2 | 2026-06-23 | Warnings, Adverse reactions | Ampicillin and Sulbactam |
| Ampicillin and Sulbactam | AMPICILLIN AND SULBACTAM | WG Critical Care, LLC | 9a722de6-9dc0-4fb9-b63a-225385aa3314 | 2026-06-23 | Warnings, Adverse reactions | Ampicillin and Sulbactam |
| Ampicillin and Sulbactam | AMPICILLIN AND SULBACTAM | WG Critical Care, LLC | 77158167-0c1e-4f01-a5b0-a3df8ad121f5 | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | Ampicillin and Sulbactam |
| Ampicillin and Sulbactam | AMPICILLIN SODIUM AND SULBACTAM SODIUM | Meitheal Pharmaceuticals Inc. | e6cf14a8-3ed9-4a7a-ba69-be0b794cbdc4 | 2026-06-10 | Warnings, Adverse reactions | Ampicillin and Sulbactam |
| Ampicillin and Sulbactam | AMPICILLIN SODIUM AND SULBACTAM SODIUM | Medical Purchasing Solutions, LLC. | 4e81c215-2ab6-87c6-e063-6294a90ac28c | 2026-04-02 | Warnings, Adverse reactions | Ampicillin and Sulbactam |
| Ampicillin and Sulbactam | AMPICILLIN AND SULBACTAM | Hikma Pharmaceuticals USA Inc. | a65a70bf-4283-4bc0-b576-00c9ab29bd64 | 2026-03-25 | Warnings, Adverse reactions | Ampicillin and Sulbactam |
| Ampicillin and Sulbactam | AMPICILLIN AND SULBACTAM | Hikma Pharmaceuticals USA Inc. | d3026cc0-95d8-44cf-be47-b5ebb8fd4568 | 2026-03-25 | Warnings, Adverse reactions | Ampicillin and Sulbactam |
| Ampicillin and Sulbactam | AMPICILLIN SODIUM AND SULBACTAM SODIUM | Hospira, Inc | dc374fa4-350b-425d-a7db-7099fdc64cf1 | 2026-01-21 | Warnings, Adverse reactions | Ampicillin and Sulbactam |
| Ampicillin and Sulbactam | AMPICILLIN SODIUM AND SULBACTAM SODIUM | Eugia US LLC | 437a26f4-776b-4f74-99b2-09ad79831b0c | 2025-12-18 | Warnings, Adverse reactions | Ampicillin and Sulbactam |
| Ampicillin and Sulbactam | AMPICILLIN SODIUM AND SULBACTAM SODIUM | Eugia US LLC | 16fdfdb9-9e26-48d0-8838-570d30c8e897 | 2025-11-04 | Warnings, Adverse reactions | Ampicillin and Sulbactam |
| Ampicillin and Sulbactam | AMPICILLIN SODIUM AND SULBACTAM SODIUM | Eugia US LLC | adc92303-b62b-41c8-becf-9c3a4e8c3a6b | 2025-08-12 | Warnings, Adverse reactions | Ampicillin and Sulbactam |
| Ampicillin and Sulbactam | AMPICILLIN SODIUM AND SULBACTAM SODIUM | Eugia US LLC | 2709e9fc-2341-4382-af72-c2e3201bd77a | 2025-08-12 | Warnings, Adverse reactions | Ampicillin and Sulbactam |
| Ampicillin and Sulbactam | AMPICILLIN SODIUM AND SULBACTAM SODIUM | Meitheal Pharmaceuticals Inc. | 9f2ff165-2a21-4155-a4f0-57885a83c7dc | 2025-07-24 | Warnings, Adverse reactions | Ampicillin and Sulbactam |
| Ampicillin and Sulbactam | AMPICILLIN AND SULBACTAM | Avenacy, LLC | 577dd6f0-d56a-4c82-9f72-274c3a4a0f01 | 2025-04-25 | Warnings, Adverse reactions | Ampicillin and Sulbactam |
| Ampicillin and Sulbactam | AMPICILLIN AND SULBACTAM | Avenacy, LLC | 4446d4c8-056d-4bc3-8f58-21255b063398 | 2025-04-25 | Warnings, Adverse reactions | Ampicillin and Sulbactam |
| ampicillin and sulbactam | AMPICILLIN AND SULBACTAM | Sagent Pharmaceuticals | 35606b43-5914-423c-9bc7-fa3957eb2563 | 2024-11-18 | Warnings, Adverse reactions | ampicillin and sulbactam |
| Ampicillin and Sulbactam | AMPICILLIN SODIUM AND SULBACTAM SODIUM | NorthStar Rx, LLC | 5e8d35cb-e93d-42ad-a02c-0dbf04910f61 | 2024-08-13 | Warnings, Adverse reactions | Ampicillin and Sulbactam |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.