Application 040557
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | INJECTABLE;INJECTION | 40MG/ML | No | No |
| 002 | METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | INJECTABLE;INJECTION | 80MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040557-001 | METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | |
| A040557-002 | METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040557-001 | AB |
| A040557-002 | AB |
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 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040557-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040557-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040557-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040557-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040557-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040557-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040557-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040557-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040557-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040557-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040557-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040557-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040557-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040557-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040557-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040557-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040557-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040557-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040557-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040557-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040557-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040557-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040557-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040557-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040557-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040557-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040557-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040557-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040557-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A040557-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040557-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040557-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040557-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040557-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040557-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040557-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040557-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040557-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040557-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040557-002 | AB | 1 | bb7c543d1eb4… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0703-0031 | Methylprednisolone Acetate | Methylprednisolone Acetate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-0031 | Methylprednisolone Acetate | Methylprednisolone Acetate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-0031 | Methylprednisolone Acetate | Methylprednisolone Acetate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-0031 | Methylprednisolone Acetate | Methylprednisolone Acetate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-0031 | Methylprednisolone Acetate | Methylprednisolone Acetate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-0031 | Methylprednisolone Acetate | Methylprednisolone Acetate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-0051 | Methylprednisolone Acetate | Methylprednisolone Acetate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-0051 | Methylprednisolone Acetate | Methylprednisolone Acetate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-0051 | Methylprednisolone Acetate | Methylprednisolone Acetate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-0051 | Methylprednisolone Acetate | Methylprednisolone Acetate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-0051 | Methylprednisolone Acetate | Methylprednisolone Acetate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-0051 | Methylprednisolone Acetate | Methylprednisolone Acetate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 16714-088 | Methylprednisolone Acetate | Methylprednisolone Acetate | Northstar RxLLC | ANDA | Current |
| 16714-088 | Methylprednisolone Acetate | Methylprednisolone Acetate | Northstar RxLLC | ANDA | Current |
| 16714-088 | Methylprednisolone Acetate | Methylprednisolone Acetate | Northstar RxLLC | ANDA | Current |
| 16714-472 | Methylprednisolone Acetate | Methylprednisolone Acetate | Northstar RxLLC | ANDA | Current |
| 16714-472 | Methylprednisolone Acetate | Methylprednisolone Acetate | Northstar RxLLC | ANDA | Current |
| 16714-472 | Methylprednisolone Acetate | Methylprednisolone Acetate | Northstar RxLLC | ANDA | Current |
| 50090-4758 | Methylprednisolone Acetate | Methylprednisolone Acetate | A-S Medication Solutions | ANDA | Current |
| 50090-4802 | Methylprednisolone Acetate | Methylprednisolone Acetate | A-S Medication Solutions | ANDA | Current |
| 50090-4802 | Methylprednisolone Acetate | Methylprednisolone Acetate | A-S Medication Solutions | ANDA | Current |
| 50090-4802 | Methylprednisolone Acetate | Methylprednisolone Acetate | A-S Medication Solutions | ANDA | Current |
| 51662-1429 | METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1429 | METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 63187-474 | Methylprednisolone Acetate | Methylprednisolone Acetate | Proficient Rx LP | ANDA | Current |
| 63187-474 | Methylprednisolone Acetate | Methylprednisolone Acetate | Proficient Rx LP | ANDA | Current |
| 70518-2894 | Methylprednisolone Acetate | Methylprednisolone Acetate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2894 | Methylprednisolone Acetate | Methylprednisolone Acetate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2894 | Methylprednisolone Acetate | Methylprednisolone Acetate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2965 | Methylprednisolone Acetate | Methylprednisolone Acetate | REMEDYREPACK INC. | ANDA | Current |