Application 207349
- Type
- ANDA
- Sponsor
- HQ SPCLT PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | MAGNESIUM SULFATE | INJECTABLE;INJECTION | 1GM/100ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207349-001 | AP |
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 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207349-001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | 2016-03-02 | 3a93d1ddd44b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A207349-001 | AP | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A207349-001 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A207349-001 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A207349-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207349-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207349-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207349-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207349-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207349-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207349-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207349-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207349-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207349-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207349-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207349-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207349-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A207349-001 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207349-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A207349-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A207349-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A207349-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A207349-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A207349-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207349-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A207349-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A207349-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A207349-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A207349-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A207349-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A207349-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207349-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A207349-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A207349-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207349-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207349-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207349-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207349-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A207349-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A207349-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207349-001 | AP | 1 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Epsom Salt | MAGNESIUM SULFATE | Discount Drug Mart | b05a94d2-5cc6-4989-9fb8-096e54fa7852 | 2026-02-04 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | Grocery Outlet, Inc. | 3dff4b00-e71a-1dc0-e063-6394a90a715f | 2026-02-04 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | HARRIS TEETER | 73065a04-b7cd-437d-9624-f845f5ec93bf | 2026-02-04 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | Hy-Vee, Inc. | 44592ee0-13dd-57b1-e063-6394a90ab402 | 2026-02-04 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | CVS Pharmacy, Inc. | a78d991a-ba21-4bc4-b8f9-f8dafbddc28f | 2026-02-03 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | Sam's West, Inc | 6edb7688-0a64-4a7e-a0c0-9f75c96682fe | 2026-02-03 | Warnings | MAGNESIUM SULFATE |
| ROYAL Epsom Salt | MAGNESIUM SULFATE | Filo America | 40eb04d2-fcc9-4ee2-8483-99699ea7e386 | 2026-01-22 | Warnings | MAGNESIUM SULFATE |
| Magnesium Sulfate | MAGNESIUM SULFATE | Henry Schein, Inc. | c255b8a9-68da-49c1-897b-bc18b731e459 | 2025-10-31 | Warnings | MAGNESIUM SULFATE |
| Magnesium Sulfate | MAGNESIUM SULFATE | Henry Schein, Inc. | 5176ed24-015e-43fe-9eb4-85098debf5f1 | 2025-10-14 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | Chain Drug Consortium, LLC | c9807e6e-9dcc-41a2-8956-b61623ac2176 | 2025-06-27 | Warnings | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | Strategic Sourcing Services LLC | 99aa30ed-9659-4f60-a31d-6aaf09909b51 | 2025-04-14 | Warnings | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | CVS PHARMACY | 30ce5cbd-cc7a-0b2d-e063-6394a90a8520 | 2025-03-20 | Warnings | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | Whole Foods Market | 5a88048e-5417-4d8e-a149-f51610a5d420 | 2025-02-19 | Warnings | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | Cardinal Health (Leader) 70000 | cde87f95-73c0-46f5-9349-37e04096048c | 2025-01-22 | Warnings | MAGNESIUM SULFATE |
| Epsom Salts | MAGNESIUM SULFATE | NEW PRIDE CORP | f6626023-4857-518b-e053-2a95a90a9821 | 2024-12-19 | Warnings | MAGNESIUM SULFATE |
| Epsom Salts | MAGNESIUM SULFATE | International Wholesale Inc. | e4d9bc32-ac85-349f-e053-2995a90a032f | 2024-12-19 | Warnings | MAGNESIUM SULFATE |
| Epsom Salts | MAGNESIUM SULFATE | International Wholesale Inc. | e5f3edc2-1b79-533a-e053-2a95a90ae9b6 | 2024-12-19 | Warnings | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | Target Corporation | f7309f4a-f1f5-420e-bfc7-fb4495a5afba | 2024-10-24 | Warnings | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | Target Corporation | 2540ae39-2218-0f6a-e063-6294a90a5efc | 2024-10-24 | Warnings | MAGNESIUM SULFATE |
| NATURAL Epsom Salt | MAGNESIUM SULFATE | Universal Distribution Center LLC | b2682e51-ffa4-4556-b2a6-b0dbd543fd4f | 2024-10-16 | Warnings | MAGNESIUM SULFATE |
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 |
|---|---|---|---|---|---|
| 44567-410 | Magnesium Sulfate | Magnesium Sulfate | WG Critical Care, LLC | ANDA | Current |
| 44567-410 | Magnesium Sulfate | Magnesium Sulfate | WG Critical Care, LLC | ANDA | Current |
| 44567-410 | Magnesium Sulfate | Magnesium Sulfate | WG Critical Care, LLC | ANDA | Current |
| 44567-410 | Magnesium Sulfate | Magnesium Sulfate | WG Critical Care, LLC | ANDA | Current |