Home Applications 209097 Application 209097
Type ANDA
Sponsor LUPIN LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 2MG No No 002 METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 4MG No No 003 METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 8MG No No 004 METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 16MG No No 005 METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 32MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209097-001 METHYLPREDNISOLONE METHYLPREDNISOLONE 2MG TABLET / ORAL 2019-02-22 A209097-002 METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET / ORAL 2019-02-22 A209097-003 METHYLPREDNISOLONE METHYLPREDNISOLONE 8MG TABLET / ORAL 2019-02-22 A209097-004 METHYLPREDNISOLONE METHYLPREDNISOLONE 16MG TABLET / ORAL 2019-02-22 A209097-005 METHYLPREDNISOLONE METHYLPREDNISOLONE 32MG TABLET / ORAL 2019-02-22
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 6 · 205 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 A209097-001 METHYLPREDNISOLONE 2MG TABLET / ORAL 2019-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209097-002 METHYLPREDNISOLONE 4MG TABLET / ORAL 2019-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209097-003 METHYLPREDNISOLONE 8MG TABLET / ORAL 2019-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209097-004 METHYLPREDNISOLONE 16MG TABLET / ORAL 2019-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209097-005 METHYLPREDNISOLONE 32MG TABLET / ORAL 2019-02-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209097-001 METHYLPREDNISOLONE 2MG TABLET / ORAL 2019-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209097-002 METHYLPREDNISOLONE 4MG TABLET / ORAL 2019-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209097-003 METHYLPREDNISOLONE 8MG TABLET / ORAL 2019-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209097-004 METHYLPREDNISOLONE 16MG TABLET / ORAL 2019-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209097-005 METHYLPREDNISOLONE 32MG TABLET / ORAL 2019-02-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209097-001 METHYLPREDNISOLONE 2MG TABLET / ORAL 2019-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209097-002 METHYLPREDNISOLONE 4MG TABLET / ORAL 2019-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209097-003 METHYLPREDNISOLONE 8MG TABLET / ORAL 2019-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209097-004 METHYLPREDNISOLONE 16MG TABLET / ORAL 2019-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209097-005 METHYLPREDNISOLONE 32MG TABLET / ORAL 2019-02-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209097-001 METHYLPREDNISOLONE 2MG TABLET / ORAL 2019-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209097-002 METHYLPREDNISOLONE 4MG TABLET / ORAL 2019-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209097-003 METHYLPREDNISOLONE 8MG TABLET / ORAL 2019-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209097-004 METHYLPREDNISOLONE 16MG TABLET / ORAL 2019-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209097-005 METHYLPREDNISOLONE 32MG TABLET / ORAL 2019-02-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209097-001 METHYLPREDNISOLONE 2MG TABLET / ORAL 2019-02-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209097-002 METHYLPREDNISOLONE 4MG TABLET / ORAL 2019-02-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209097-003 METHYLPREDNISOLONE 8MG TABLET / ORAL 2019-02-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209097-004 METHYLPREDNISOLONE 16MG TABLET / ORAL 2019-02-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209097-005 METHYLPREDNISOLONE 32MG TABLET / ORAL 2019-02-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209097-001 METHYLPREDNISOLONE 2MG TABLET / ORAL 2019-02-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209097-002 METHYLPREDNISOLONE 4MG TABLET / ORAL 2019-02-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209097-003 METHYLPREDNISOLONE 8MG TABLET / ORAL 2019-02-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209097-004 METHYLPREDNISOLONE 16MG TABLET / ORAL 2019-02-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209097-005 METHYLPREDNISOLONE 32MG TABLET / ORAL 2019-02-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209097-001 METHYLPREDNISOLONE 2MG TABLET / ORAL 2019-02-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209097-002 METHYLPREDNISOLONE 4MG TABLET / ORAL 2019-02-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209097-003 METHYLPREDNISOLONE 8MG TABLET / ORAL 2019-02-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209097-004 METHYLPREDNISOLONE 16MG TABLET / ORAL 2019-02-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209097-005 METHYLPREDNISOLONE 32MG TABLET / ORAL 2019-02-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209097-001 METHYLPREDNISOLONE 2MG TABLET / ORAL 2019-02-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209097-002 METHYLPREDNISOLONE 4MG TABLET / ORAL 2019-02-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209097-003 METHYLPREDNISOLONE 8MG TABLET / ORAL 2019-02-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209097-004 METHYLPREDNISOLONE 16MG TABLET / ORAL 2019-02-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209097-005 METHYLPREDNISOLONE 32MG TABLET / ORAL 2019-02-22 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 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68180-685 methylprednisolone methylprednisolone Lupin Pharmaceuticals, Inc. ANDA Current 68180-685 methylprednisolone methylprednisolone Lupin Pharmaceuticals, Inc. ANDA Current 68180-686 methylprednisolone methylprednisolone Lupin Pharmaceuticals, Inc. ANDA Current 68180-686 methylprednisolone methylprednisolone Lupin Pharmaceuticals, Inc. ANDA Current 68180-687 methylprednisolone methylprednisolone Lupin Pharmaceuticals, Inc. ANDA Current 68180-687 methylprednisolone methylprednisolone Lupin Pharmaceuticals, Inc. ANDA Current 68180-688 methylprednisolone methylprednisolone Lupin Pharmaceuticals, Inc. ANDA Current 68180-688 methylprednisolone methylprednisolone Lupin Pharmaceuticals, Inc. ANDA Current 68180-689 methylprednisolone methylprednisolone Lupin Pharmaceuticals, Inc. ANDA Current 68180-689 methylprednisolone methylprednisolone Lupin Pharmaceuticals, Inc. ANDA Current