Home Applications 040232 Application 040232
Type ANDA
Sponsor WATSON LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 4MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040232-001 METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040232-001 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.
Product history page 1 of 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040232-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 PD-Rx Pharmaceuticals, Inc. a14c4f76-6dd5-4c84-b6e5-e5abf19ab559 2025-03-20 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
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0591-0790 Methylprednisolone Methylprednisolone Actavis Pharma, Inc. ANDA Current 0591-0790 Methylprednisolone Methylprednisolone Actavis Pharma, Inc. ANDA Current 0591-0790 Methylprednisolone Methylprednisolone Actavis Pharma, Inc. ANDA Current 50090-2638 Methylprednisolone Methylprednisolone A-S Medication Solutions ANDA Current 63187-802 Methylprednisolone Methylprednisolone Proficient Rx LP ANDA Current 63187-802 Methylprednisolone Methylprednisolone Proficient Rx LP ANDA Current 63187-802 Methylprednisolone Methylprednisolone Proficient Rx LP ANDA Current 66267-961 Methylprednisolone Methylprednisolone NuCare Pharmaceuticals,Inc. ANDA Current 66267-961 Methylprednisolone Methylprednisolone NuCare Pharmaceuticals,Inc. ANDA Current