Application 207667
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | INJECTABLE;INJECTION | EQ 40MG BASE/VIAL | No | No |
| 002 | METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | INJECTABLE;INJECTION | EQ 125MG BASE/VIAL | No | No |
| 003 | METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No |
| 004 | METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207667-001 | METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 40MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | ||
| A207667-002 | METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | ||
| A207667-003 | METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | ||
| A207667-004 | METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 |
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 | A207667-001 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 40MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207667-002 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207667-003 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207667-004 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207667-001 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 40MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207667-002 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207667-003 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207667-004 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207667-001 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 40MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207667-002 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207667-003 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207667-004 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207667-001 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 40MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207667-002 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207667-003 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207667-004 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207667-001 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 40MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207667-002 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207667-003 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207667-004 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207667-001 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 40MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207667-002 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207667-003 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207667-004 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207667-001 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 40MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207667-002 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207667-003 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207667-004 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207667-001 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 40MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207667-002 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207667-003 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207667-004 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207667-001 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 40MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207667-002 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207667-003 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207667-004 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207667-001 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 40MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207667-002 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207667-003 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207667-004 | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2015-12-15 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207667-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207667-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207667-003 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207667-004 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A207667-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A207667-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A207667-003 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A207667-004 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A207667-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A207667-002 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A207667-003 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A207667-004 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A207667-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A207667-002 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A207667-003 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A207667-004 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A207667-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A207667-002 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A207667-003 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A207667-004 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A207667-001 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A207667-002 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A207667-003 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A207667-004 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207667-001 | AP | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207667-002 | AP | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207667-003 | AP | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207667-004 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A207667-001 | AP | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A207667-002 | AP | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A207667-003 | AP | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A207667-004 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A207667-001 | AP | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A207667-002 | AP | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A207667-003 | AP | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A207667-004 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A207667-001 | AP | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A207667-002 | AP | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A207667-003 | AP | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A207667-004 | AP | 1 | c0c555d07b60… |
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 |
|---|---|---|---|---|---|---|
| Methylprednisolone Sodium Succinate | METHYLPREDNISOLONE SODIUM SUCCINATE | Eugia US LLC | 2035f00e-2299-473a-b004-cb93f541cfa9 | 2026-06-12 | Warnings, Adverse reactions | 207667 ANDA207667 55150-265 55150-263 55150-264 55150-262 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55150-262 | Methylprednisolone Sodium Succinate | Methylprednisolone Sodium Succinate | AuroMedics Pharma LLC | ANDA | Current |
| 55150-262 | Methylprednisolone Sodium Succinate | Methylprednisolone Sodium Succinate | AuroMedics Pharma LLC | ANDA | Current |
| 55150-262 | Methylprednisolone Sodium Succinate | Methylprednisolone Sodium Succinate | AuroMedics Pharma LLC | ANDA | Current |
| 55150-263 | Methylprednisolone Sodium Succinate | Methylprednisolone Sodium Succinate | AuroMedics Pharma LLC | ANDA | Current |
| 55150-263 | Methylprednisolone Sodium Succinate | Methylprednisolone Sodium Succinate | AuroMedics Pharma LLC | ANDA | Current |
| 55150-263 | Methylprednisolone Sodium Succinate | Methylprednisolone Sodium Succinate | AuroMedics Pharma LLC | ANDA | Current |
| 55150-264 | Methylprednisolone Sodium Succinate | Methylprednisolone Sodium Succinate | AuroMedics Pharma LLC | ANDA | Current |
| 55150-264 | Methylprednisolone Sodium Succinate | Methylprednisolone Sodium Succinate | AuroMedics Pharma LLC | ANDA | Current |
| 55150-264 | Methylprednisolone Sodium Succinate | Methylprednisolone Sodium Succinate | AuroMedics Pharma LLC | ANDA | Current |
| 55150-265 | Methylprednisolone Sodium Succinate | Methylprednisolone Sodium Succinate | AuroMedics Pharma LLC | ANDA | Current |
| 55150-265 | Methylprednisolone Sodium Succinate | Methylprednisolone Sodium Succinate | AuroMedics Pharma LLC | ANDA | Current |
| 55150-265 | Methylprednisolone Sodium Succinate | Methylprednisolone Sodium Succinate | AuroMedics Pharma LLC | ANDA | Current |