Home Applications 040194 Application 040194
Type ANDA
Sponsor SANDOZ 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 A040194-001 METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040194-001 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 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040194-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 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 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 20 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0781-5022 Methylprednisolone Methylprednisolone Sandoz Inc ANDA Current 0781-5022 Methylprednisolone Methylprednisolone Sandoz Inc ANDA Current 0781-5022 Methylprednisolone Methylprednisolone Sandoz Inc ANDA Current 45865-104 Methylprednisolone Methylprednisolone Medsource Pharmaceuticals ANDA Current 60760-373 Methylprednisolone Methylprednisolone St. Mary's Medical Park Pharmacy ANDA Current 68071-2301 Methylprednisolone Methylprednisolone NuCare Pharmaceuticals,Inc. ANDA Current 68071-2301 Methylprednisolone Methylprednisolone NuCare Pharmaceuticals,Inc. ANDA Current 68071-4262 Methylprednisolone Methylprednisolone NuCare Pharmaceuticals,Inc. ANDA Current 68788-7343 Methylprednisolone Methylprednisolone Preferred Pharmaceuticals Inc. ANDA Current 68788-7343 Methylprednisolone Methylprednisolone Preferred Pharmaceuticals Inc. ANDA Current 70518-1541 Methylprednisolone Methylprednisolone REMEDYREPACK INC. ANDA Current 70518-1541 Methylprednisolone Methylprednisolone REMEDYREPACK INC. ANDA Current 70518-1541 Methylprednisolone Methylprednisolone REMEDYREPACK INC. ANDA Current 70518-1541 Methylprednisolone Methylprednisolone REMEDYREPACK INC. ANDA Current 70518-1541 Methylprednisolone Methylprednisolone REMEDYREPACK INC. ANDA Current 71205-054 Methylprednisolone Methylprednisolone Proficient Rx LP ANDA Current 71205-054 Methylprednisolone Methylprednisolone Proficient Rx LP ANDA Current 71205-054 Methylprednisolone Methylprednisolone Proficient Rx LP ANDA Current 72189-008 Methylpred DP Methylpred DP Direct_Rx ANDA Current 72189-008 Methylpred DP Methylpred DP Direct_Rx ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 22093 ORIG 2011-05-06