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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A040557-001 | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A040557-002 | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE / INJECTION | AB | 2005-02-23 | 84e616aacf4f… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A040557-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A040557-002 | AB | 1 | 84e616aacf4f… |
| 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… |
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 |
|---|---|---|---|---|---|---|
| Depo-Medrol | METHYLPREDNISOLONE ACETATE | Asclemed USA, Inc. | cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6 | 2022-10-12 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
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 |
|---|---|---|---|---|---|
| 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 |