Application 207198
- Type
- ANDA
- Sponsor
- DR REDDYS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, 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 |
|---|---|---|---|---|---|---|---|
| A207198-001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2024-04-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207198-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2024-04-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207198-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2024-04-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207198-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2024-04-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207198-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2024-04-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207198-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2024-04-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207198-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2024-04-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207198-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2024-04-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207198-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2024-04-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207198-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2024-04-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207198-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2024-04-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207198-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2024-04-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207198-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2024-04-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207198-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2024-04-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207198-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2024-04-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207198-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2024-04-30 | 8072bd15b7f6… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A207198-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2024-04-30 | 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 |
|---|---|---|---|---|---|---|
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | Dr. Reddy's Laboratories Inc | 8bceb7b3-d0a4-6e53-6957-8104a6b927e4 | 2025-11-04 | Warnings | 207198 ANDA207198 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | KROGER COMPANY | d001e9c2-1c70-7ff6-ad72-c431a46d1771 | 2025-10-28 | Warnings | 207198 ANDA207198 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | WALGREENS COMPANY | 993f86d0-c18b-a843-6adf-e8a967da3745 | 2025-10-28 | Warnings | 207198 ANDA207198 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1edcb0be-7af2-c08c-dab2-0be03364a140 | 2025-10-28 | Warnings | 207198 ANDA207198 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | H E B | a5a6f614-2920-d74c-1ddc-9a07a0ec6e05 | 2025-10-28 | Warnings | 207198 ANDA207198 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | DISCOUNT DRUG MART, INC. | 144fcd6b-2b40-f84b-c559-07a847b27638 | 2024-11-30 | Warnings | 207198 ANDA207198 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | Dr. Reddy's Laboratories Inc | fab0b1fa-cf56-d97c-f026-1754cf5b792c | 2024-07-08 | Warnings | 207198 ANDA207198 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | Dr. Reddy's Laboratories Inc | fca35363-7d27-b8b3-14c0-56f603652053 | 2024-06-24 | Warnings | 207198 ANDA207198 |