Application 206582
- Type
- ANDA
- Sponsor
- ACTAVIS ELIZABETH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OMEPRAZOLE MAGNESIUM | OMEPRAZOLE MAGNESIUM | TABLET, DELAYED RELEASE;ORAL | EQ 20MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206582-001 | OMEPRAZOLE MAGNESIUM | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | c0c555d07b60… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Prilosec OTC | OMEPRAZOLE MAGNESIUM | The Procter & Gamble Manufacturing Company | 37291cab-e350-d8e3-e063-6294a90a9cb1 | 2026-07-29 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | P & L Development, LLC | 883e428a-e157-4bbf-8657-e7a93dc99e8c | 2026-07-14 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | WALMART INC. (see also Equate) | d3c1ba08-680d-4e39-875c-1f1d42ae787c | 2026-07-13 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | PLD Acquisitions LLC DBA Avma Pharma Solutions | d9c8a242-bdba-4f92-8629-692b47ebba21 | 2026-06-26 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | PLD Acquisitions LLC DBA Avma Pharma Solutions | 71add294-ff24-4bbf-9067-7c56ed7c9f1a | 2026-06-26 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | PLD Acquisitions LLC DBA Avma Pharma Solutions | e67bf2c6-0618-48e0-aa08-705501d86431 | 2026-06-26 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | PLD Acquisitions LLC DBA Avma Pharma Solutions | 6a1aeb95-5760-4363-816a-fa8305979c50 | 2026-06-26 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | P & L Development, LLC | 911a08c4-ba73-4600-a5f2-7f26ba8c8604 | 2026-06-25 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | Walgreens | b9683a94-fd44-4364-be0e-477ca1a29aba | 2026-03-27 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | WinCo Foods, LLC | 2782b98b-50e4-4a4e-8626-d34ebfd71bfb | 2026-01-14 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | Family Dollar (FAMILY WELLNESS) | f2195d73-1fd5-4de2-aa5c-18741d11f4fc | 2025-10-30 | Warnings | 206582 ANDA206582 |
| Prilosec OTC | OMEPRAZOLE MAGNESIUM | The Procter & Gamble Manufacturing Company | c7229a69-07e7-4690-8fc0-1f0f093bf230 | 2025-06-10 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | P & L Development, LLC | 44a92926-1941-4fe8-9b2a-31a45289456f | 2025-06-02 | Warnings | 206582 ANDA206582 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59726-297 | Omeprazole | Omeprazole magnesium | P & L Development, LLC | ANDA | Current |
| 59726-297 | Omeprazole | Omeprazole magnesium | P & L Development, LLC | ANDA | Current |
| 59726-737 | Omeprazole | Omeprazole magnesium | P & L Development, LLC | ANDA | Current |
| 59726-737 | Omeprazole | Omeprazole magnesium | P & L Development, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 50730 | ORIG | 2017-12-18 |