Application 209145
- Type
- ANDA
- Sponsor
- SUN PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ERTAPENEM SODIUM | ERTAPENEM SODIUM | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | EQ 1GM BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209145-001 | ERTAPENEM SODIUM | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2023-05-02 |
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 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2023-05-02 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2023-05-02 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2023-05-02 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2023-05-02 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2023-05-02 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2023-05-02 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2023-05-02 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2023-05-02 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2023-05-02 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2023-05-02 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2023-05-02 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2023-05-02 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2023-05-02 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2023-05-02 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2023-05-02 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2023-05-02 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2023-05-02 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2023-05-02 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | AP | 2023-05-02 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | AP | 2023-05-02 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | AP | 2023-05-02 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | AP | 2023-05-02 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | AP | 2023-05-02 | 3f0d92c62455… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209145-001 | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2023-05-02 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-12-20 04:57 UTC | 2023-12 | A209145-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209145-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209145-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209145-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209145-001 | AP | 1 | 3f0d92c62455… |
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 |
|---|---|---|---|---|---|---|
| ERTAPENEM | ERTAPENEM SODIUM | ENDO USA, Inc. | 41304b1d-7db4-468a-ab1d-04e56fb50de4 | 2026-03-02 | Warnings, Adverse reactions | ERTAPENEM SODIUM |
| ERTAPENEM | ERTAPENEM SODIUM | ENDO USA, Inc. | 657855f2-7c92-4aa8-9c3d-51d08e56a09a | 2026-03-02 | Warnings, Adverse reactions | ERTAPENEM SODIUM |
| INVANZ | ERTAPENEM SODIUM | Merck Sharp & Dohme LLC | 33f3b99b-fa82-42e0-26bf-f49891ae3d22 | 2026-02-04 | Warnings, Adverse reactions | ERTAPENEM SODIUM |
| Ertapenem | ERTAPENEM SODIUM | Sagent Pharmaceuticals | 124775ed-1271-4581-be52-b7a08c91283d | 2026-01-09 | Warnings, Adverse reactions | ERTAPENEM SODIUM |
| ERTAPENEM SODIUM | ERTAPENEM | NorthStar RxLLC | 2398d418-6efc-b4d2-3265-936001df9b8b | 2025-12-24 | Warnings, Adverse reactions | ERTAPENEM SODIUM |
| Ertapenem | ERTAPENEM SODIUM | Qilu Antibiotics Pharmaceutical Co., Ltd. | 44496f7c-8407-4765-9cd6-1daa619a6db6 | 2025-09-03 | Warnings, Adverse reactions | ERTAPENEM SODIUM |
| Ertapenem | ERTAPENEM SODIUM | Sagent Pharmaceuticals | 39bd4d41-36f8-4826-a733-a5ad1a531c02 | 2025-08-17 | Warnings, Adverse reactions | ERTAPENEM SODIUM |
| ertapenem sodium | ERTAPENEM SODIUM | Hikma Pharmaceuticals USA, Inc. | a400707f-763f-43f6-989e-0d2569d822d8 | 2024-11-06 | Warnings, Adverse reactions | ertapenem sodium ERTAPENEM SODIUM |
| Ertapenem | ERTAPENEM SODIUM | Hikma Pharmaceuticals USA Inc. | b88c0709-33fe-47db-8ae8-8bad6692d5d5 | 2024-11-05 | Warnings, Adverse reactions | ERTAPENEM SODIUM |
| Ertapenem | ERTAPENEM SODIUM | Fosun Pharma USA Inc | c398450c-2b72-86a4-e053-2995a90ad1f0 | 2024-05-10 | Warnings, Adverse reactions | ERTAPENEM SODIUM |
| Ertapenem | ERTAPENEM SODIUM | BluePoint Laboratories | 8eccc96f-4b59-49ee-9997-365a24f59a24 | 2024-03-05 | Warnings, Adverse reactions | ERTAPENEM SODIUM |
| Ertapenem | ERTAPENEM SODIUM | Apotex Corp | 468105b9-48b3-4477-82c7-e7fb92460e28 | 2023-12-13 | Warnings, Adverse reactions | ERTAPENEM SODIUM |
| Ertapenem | ERTAPENEM SODIUM | Savior Lifetec Corporation | c4da28cb-6725-4fa1-a7b0-e84f408fb36b | 2023-11-27 | Warnings, Adverse reactions | ERTAPENEM SODIUM |
| Ertapenem | ERTAPENEM SODIUM | Fresenius Kabi USA, LLC | 666c9f33-ea9e-4667-b8bd-f8b1b6b6be51 | 2022-11-08 | Warnings, Adverse reactions | ERTAPENEM SODIUM |
| Ertapenem | ERTAPENEM SODIUM | Gland Pharma Limited | f74cca2f-e775-4580-acae-3a0c47dd24d9 | 2022-04-12 | Warnings, Adverse reactions | ERTAPENEM SODIUM |
| ERTAPENEM SODIUM | ERTAPENEM | Dr.Reddys Laboratories Inc., | 32d9f095-ca39-7e22-6264-b54f2daaee57 | 2021-04-30 | Warnings, Adverse reactions | ERTAPENEM SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.