Home Applications 207481 Application 207481
Type ANDA
Sponsor AMNEAL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 4MG No No 002 METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 8MG No No 003 METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 16MG No No 004 METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 32MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207481-001 METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET / ORAL 2021-09-21 A207481-002 METHYLPREDNISOLONE METHYLPREDNISOLONE 8MG TABLET / ORAL 2021-09-21 A207481-003 METHYLPREDNISOLONE METHYLPREDNISOLONE 16MG TABLET / ORAL 2021-09-21 A207481-004 METHYLPREDNISOLONE METHYLPREDNISOLONE 32MG TABLET / ORAL 2021-09-21
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.
Product history page 1 of 4 · 140 observed states.
Captured, Edition, Application-product table 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 A207481-001 METHYLPREDNISOLONE 4MG TABLET / ORAL 2021-09-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207481-002 METHYLPREDNISOLONE 8MG TABLET / ORAL 2021-09-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207481-003 METHYLPREDNISOLONE 16MG TABLET / ORAL 2021-09-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207481-004 METHYLPREDNISOLONE 32MG TABLET / ORAL 2021-09-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207481-001 METHYLPREDNISOLONE 4MG TABLET / ORAL 2021-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207481-002 METHYLPREDNISOLONE 8MG TABLET / ORAL 2021-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207481-003 METHYLPREDNISOLONE 16MG TABLET / ORAL 2021-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207481-004 METHYLPREDNISOLONE 32MG TABLET / ORAL 2021-09-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207481-001 METHYLPREDNISOLONE 4MG TABLET / ORAL 2021-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207481-002 METHYLPREDNISOLONE 8MG TABLET / ORAL 2021-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207481-003 METHYLPREDNISOLONE 16MG TABLET / ORAL 2021-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207481-004 METHYLPREDNISOLONE 32MG TABLET / ORAL 2021-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207481-001 METHYLPREDNISOLONE 4MG TABLET / ORAL 2021-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207481-002 METHYLPREDNISOLONE 8MG TABLET / ORAL 2021-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207481-003 METHYLPREDNISOLONE 16MG TABLET / ORAL 2021-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207481-004 METHYLPREDNISOLONE 32MG TABLET / ORAL 2021-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207481-001 METHYLPREDNISOLONE 4MG TABLET / ORAL 2021-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207481-002 METHYLPREDNISOLONE 8MG TABLET / ORAL 2021-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207481-003 METHYLPREDNISOLONE 16MG TABLET / ORAL 2021-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207481-004 METHYLPREDNISOLONE 32MG TABLET / ORAL 2021-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207481-001 METHYLPREDNISOLONE 4MG TABLET / ORAL 2021-09-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207481-002 METHYLPREDNISOLONE 8MG TABLET / ORAL 2021-09-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207481-003 METHYLPREDNISOLONE 16MG TABLET / ORAL 2021-09-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207481-004 METHYLPREDNISOLONE 32MG TABLET / ORAL 2021-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207481-001 METHYLPREDNISOLONE 4MG TABLET / ORAL 2021-09-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207481-002 METHYLPREDNISOLONE 8MG TABLET / ORAL 2021-09-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207481-003 METHYLPREDNISOLONE 16MG TABLET / ORAL 2021-09-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207481-004 METHYLPREDNISOLONE 32MG TABLET / ORAL 2021-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207481-001 METHYLPREDNISOLONE 4MG TABLET / ORAL 2021-09-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207481-002 METHYLPREDNISOLONE 8MG TABLET / ORAL 2021-09-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207481-003 METHYLPREDNISOLONE 16MG TABLET / ORAL 2021-09-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207481-004 METHYLPREDNISOLONE 32MG TABLET / ORAL 2021-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207481-001 METHYLPREDNISOLONE 4MG TABLET / ORAL 2021-09-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207481-002 METHYLPREDNISOLONE 8MG TABLET / ORAL 2021-09-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207481-003 METHYLPREDNISOLONE 16MG TABLET / ORAL 2021-09-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207481-004 METHYLPREDNISOLONE 32MG TABLET / ORAL 2021-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207481-001 METHYLPREDNISOLONE 4MG TABLET / ORAL 2021-09-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207481-002 METHYLPREDNISOLONE 8MG TABLET / ORAL 2021-09-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207481-003 METHYLPREDNISOLONE 16MG TABLET / ORAL 2021-09-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207481-004 METHYLPREDNISOLONE 32MG TABLET / ORAL 2021-09-21 5bbf6a4d5a75…
Observed Orange Book normalized TE history# 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.
Matched openFDA labels page 2 of 2 · 38 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join methylprednisolone METHYLPREDNISOLONE Zydus Pharmaceuticals USA Inc. eaa9c932-c659-4ef6-bf5a-186545d87320 2025-11-10 Warnings, Adverse reactions Name fallback brand name: methylprednisolone generic name: METHYLPREDNISOLONE METHYLPREDNISOLONE METHYLPREDNISOLONE Direct_Rx 8c3f3f63-8a05-7a4a-e053-2995a90ad95a 2025-01-20 Warnings, Adverse reactions Name fallback brand name: METHYLPREDNISOLONE generic name: METHYLPREDNISOLONE Methylprednisolone METHYLPREDNISOLONE Advanced Rx Pharmacy of Tennessee, LLC f19f6120-3c25-2a28-e053-2a95a90a86d5 2024-12-31 Warnings, Adverse reactions Name fallback brand name: Methylprednisolone generic name: METHYLPREDNISOLONE Methylprednisolone METHYLPREDNISOLONE Advanced Rx Pharmacy of Tennessee, LLC f19f4304-bf37-da04-e053-2a95a90a4044 2024-12-31 Warnings, Adverse reactions Name fallback brand name: Methylprednisolone generic name: METHYLPREDNISOLONE Methylprednisolone METHYLPREDNISOLONE Advanced Rx Pharmacy of Tennessee, LLC f19f3676-856f-e8d7-e053-2995a90ad703 2024-12-31 Warnings, Adverse reactions Name fallback brand name: Methylprednisolone generic name: METHYLPREDNISOLONE methylprednisolone METHYLPREDNISOLONE Zydus Lifesciences Limited fe9c15b5-4264-45f1-87b5-f7e1d6e6ddee 2024-12-05 Name fallback brand name: methylprednisolone generic name: METHYLPREDNISOLONE Methylprednisolone METHYLPREDNISOLONE A-S Medication Solutions eb479561-142d-410c-84b2-988375c6a96e 2024-10-02 Warnings, Adverse reactions Name fallback brand name: Methylprednisolone generic name: METHYLPREDNISOLONE Methylprednisolone METHYLPREDNISOLONE Chartwell RX, LLC bdd048bb-7e6c-45c7-b51a-075e83ca9f5b 2024-09-17 Warnings, Adverse reactions Name fallback brand name: Methylprednisolone generic name: METHYLPREDNISOLONE METHYLPREDNISOLONE METHYLPREDNISOLONE NuCare Pharmaceuticals,Inc. a1dae00d-1ad3-7493-e053-2a95a90af49f 2024-06-20 Warnings, Adverse reactions Name fallback brand name: METHYLPREDNISOLONE generic name: METHYLPREDNISOLONE MethylPREDNISolone METHYLPREDNISOLONE Bryant Ranch Prepack 01f0126c-da22-4ac0-8755-3bc589602e6a 2024-04-12 Warnings, Adverse reactions Name fallback brand name: MethylPREDNISolone generic name: METHYLPREDNISOLONE MethylPREDNISolone METHYLPREDNISOLONE Bryant Ranch Prepack cbe5f72a-b0fb-4abb-abfe-2f917d351a00 2023-09-26 Warnings, Adverse reactions Name fallback brand name: MethylPREDNISolone generic name: METHYLPREDNISOLONE methylprednisolone METHYLPREDNISOLONE Proficient Rx LP 177fd649-4339-4bfd-bd12-7e8de302412b 2023-09-01 Warnings, Adverse reactions Name fallback brand name: methylprednisolone generic name: METHYLPREDNISOLONE MethylPREDNISolone METHYLPREDNISOLONE Bryant Ranch Prepack 56c24076-3d5e-4235-a787-ec6329497084 2023-08-11 Warnings, Adverse reactions Name fallback brand name: MethylPREDNISolone generic name: METHYLPREDNISOLONE Methylprednisolone METHYLPREDNISOLONE Proficient Rx LP 283a913e-f737-478e-b6a0-e050fb6562d8 2023-07-01 Warnings, Adverse reactions Name fallback brand name: Methylprednisolone generic name: METHYLPREDNISOLONE Methylprednisolone METHYLPREDNISOLONE Asclemed USA, Inc. 8bfdc471-54f7-4298-ba2f-e5c1f6c48456 2022-10-12 Warnings, Adverse reactions Name fallback brand name: Methylprednisolone generic name: METHYLPREDNISOLONE METHYLPREDNISOLONE METHYLPREDNISOLONE Proficient Rx LP 3e37236f-8ba8-4a1c-87c8-62b787890fae 2022-03-01 Warnings, Adverse reactions Name fallback brand name: METHYLPREDNISOLONE generic name: METHYLPREDNISOLONE METHYLPREDNISOLONE METHYLPREDNISOLONE Doc Rx c6ec50b5-aeb8-40c3-83e2-af4fe8fefb14 2021-06-11 Warnings, Adverse reactions Name fallback brand name: METHYLPREDNISOLONE generic name: METHYLPREDNISOLONE METHYLPREDNISOLONE METHYLPREDNISOLONE Asclemed USA, Inc. 8bff5330-c1f6-4014-aadb-45c1726248dd 2021-03-16 Warnings, Adverse reactions Name fallback brand name: METHYLPREDNISOLONE generic name: METHYLPREDNISOLONE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 65162-871 Methylprednisolone Methylprednisolone Amneal Pharmaceuticals LLC ANDA Current 65162-871 Methylprednisolone Methylprednisolone Amneal Pharmaceuticals LLC ANDA Current 65162-980 Methylprednisolone Methylprednisolone Amneal Pharmaceuticals LLC ANDA Current 65162-980 Methylprednisolone Methylprednisolone Amneal Pharmaceuticals LLC ANDA Current 65162-982 Methylprednisolone Methylprednisolone Amneal Pharmaceuticals LLC ANDA Current 65162-982 Methylprednisolone Methylprednisolone Amneal Pharmaceuticals LLC ANDA Current 65162-984 Methylprednisolone Methylprednisolone Amneal Pharmaceuticals LLC ANDA Current 65162-984 Methylprednisolone Methylprednisolone Amneal Pharmaceuticals LLC ANDA Current