Home Applications 211575 Application 211575
Type ANDA
Sponsor NOVITIUM PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PREDNISONE PREDNISONE TABLET;ORAL 2.5MG No No 002 PREDNISONE PREDNISONE TABLET;ORAL 5MG No No 003 PREDNISONE PREDNISONE TABLET;ORAL 10MG No No 004 PREDNISONE PREDNISONE TABLET;ORAL 20MG No No 005 PREDNISONE PREDNISONE TABLET;ORAL 50MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A211575-001 PREDNISONE PREDNISONE 2.5MG TABLET / ORAL AB 2019-11-15 A211575-002 PREDNISONE PREDNISONE 5MG TABLET / ORAL AB 2019-11-15 A211575-003 PREDNISONE PREDNISONE 10MG TABLET / ORAL AB 2019-11-15 A211575-004 PREDNISONE PREDNISONE 20MG TABLET / ORAL AB 2019-11-15 A211575-005 PREDNISONE PREDNISONE 50MG TABLET / ORAL AB 2019-11-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
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 5 · 195 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 2026-08-18 06:07:40 2026-07 A211575-001 PREDNISONE 2.5MG TABLET / ORAL AB 2019-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211575-002 PREDNISONE 5MG TABLET / ORAL AB 2019-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211575-003 PREDNISONE 10MG TABLET / ORAL AB 2019-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211575-004 PREDNISONE 20MG TABLET / ORAL AB 2019-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211575-005 PREDNISONE 50MG TABLET / ORAL AB 2019-11-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211575-001 PREDNISONE 2.5MG TABLET / ORAL AB 2019-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211575-002 PREDNISONE 5MG TABLET / ORAL AB 2019-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211575-003 PREDNISONE 10MG TABLET / ORAL AB 2019-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211575-004 PREDNISONE 20MG TABLET / ORAL AB 2019-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211575-005 PREDNISONE 50MG TABLET / ORAL AB 2019-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211575-001 PREDNISONE 2.5MG TABLET / ORAL AB 2019-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211575-002 PREDNISONE 5MG TABLET / ORAL AB 2019-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211575-003 PREDNISONE 10MG TABLET / ORAL AB 2019-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211575-004 PREDNISONE 20MG TABLET / ORAL AB 2019-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211575-005 PREDNISONE 50MG TABLET / ORAL AB 2019-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211575-001 PREDNISONE 2.5MG TABLET / ORAL AB 2019-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211575-002 PREDNISONE 5MG TABLET / ORAL AB 2019-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211575-003 PREDNISONE 10MG TABLET / ORAL AB 2019-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211575-004 PREDNISONE 20MG TABLET / ORAL AB 2019-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211575-005 PREDNISONE 50MG TABLET / ORAL AB 2019-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211575-001 PREDNISONE 2.5MG TABLET / ORAL AB 2019-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211575-002 PREDNISONE 5MG TABLET / ORAL AB 2019-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211575-003 PREDNISONE 10MG TABLET / ORAL AB 2019-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211575-004 PREDNISONE 20MG TABLET / ORAL AB 2019-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211575-005 PREDNISONE 50MG TABLET / ORAL AB 2019-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211575-001 PREDNISONE 2.5MG TABLET / ORAL AB 2019-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211575-002 PREDNISONE 5MG TABLET / ORAL AB 2019-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211575-003 PREDNISONE 10MG TABLET / ORAL AB 2019-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211575-004 PREDNISONE 20MG TABLET / ORAL AB 2019-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211575-005 PREDNISONE 50MG TABLET / ORAL AB 2019-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211575-001 PREDNISONE 2.5MG TABLET / ORAL AB 2019-11-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211575-002 PREDNISONE 5MG TABLET / ORAL AB 2019-11-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211575-003 PREDNISONE 10MG TABLET / ORAL AB 2019-11-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211575-004 PREDNISONE 20MG TABLET / ORAL AB 2019-11-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211575-005 PREDNISONE 50MG TABLET / ORAL AB 2019-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211575-001 PREDNISONE 2.5MG TABLET / ORAL AB 2019-11-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211575-002 PREDNISONE 5MG TABLET / ORAL AB 2019-11-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211575-003 PREDNISONE 10MG TABLET / ORAL AB 2019-11-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211575-004 PREDNISONE 20MG TABLET / ORAL AB 2019-11-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211575-005 PREDNISONE 50MG TABLET / ORAL AB 2019-11-15 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 195 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 · 21 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 45 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42291-768 Prednisone Prednisone AvKARE ANDA Current 42291-768 Prednisone Prednisone AvKARE ANDA Current 42291-769 Prednisone Prednisone AvKARE ANDA Current 42291-769 Prednisone Prednisone AvKARE ANDA Current 42291-770 Prednisone Prednisone AvKARE ANDA Current 42291-770 Prednisone Prednisone AvKARE ANDA Current 42291-771 Prednisone Prednisone AvKARE ANDA Current 42291-771 Prednisone Prednisone AvKARE ANDA Current 50090-6225 Prednisone Prednisone A-S Medication Solutions ANDA Current 67296-1419 Prednisone Prednisone RedPharm Drug, Inc. ANDA Current 70518-3142 Prednisone Prednisone REMEDYREPACK INC. ANDA Current 70518-3142 Prednisone Prednisone REMEDYREPACK INC. ANDA Current 70518-3142 Prednisone Prednisone REMEDYREPACK INC. ANDA Current 70954-057 Prednisone Prednisone Novitium Pharma LLC ANDA Current 70954-057 Prednisone Prednisone Novitium Pharma LLC ANDA Current 70954-057 Prednisone Prednisone Novitium Pharma LLC ANDA Current 70954-058 Prednisone Prednisone Novitium Pharma LLC ANDA Current 70954-058 Prednisone Prednisone Novitium Pharma LLC ANDA Current 70954-058 Prednisone Prednisone Novitium Pharma LLC ANDA Current 70954-059 Prednisone Prednisone Novitium Pharma LLC ANDA Current 70954-059 Prednisone Prednisone Novitium Pharma LLC ANDA Current 70954-059 Prednisone Prednisone Novitium Pharma LLC ANDA Current 70954-060 Prednisone Prednisone Novitium Pharma LLC ANDA Current 70954-060 Prednisone Prednisone Novitium Pharma LLC ANDA Current 70954-060 Prednisone Prednisone Novitium Pharma LLC ANDA Current 70954-061 Prednisone Prednisone Novitium Pharma LLC ANDA Current 70954-061 Prednisone Prednisone Novitium Pharma LLC ANDA Current 70954-061 Prednisone Prednisone Novitium Pharma LLC ANDA Current 71205-407 Prednisone Prednisone Proficient Rx LP ANDA Current 71205-407 Prednisone Prednisone Proficient Rx LP ANDA Current 71205-407 Prednisone Prednisone Proficient Rx LP ANDA Current 71205-407 Prednisone Prednisone Proficient Rx LP ANDA Current 71205-421 Prednisone Prednisone Proficient Rx LP ANDA Current 71205-421 Prednisone Prednisone Proficient Rx LP ANDA Current 71205-421 Prednisone Prednisone Proficient Rx LP ANDA Current 71205-421 Prednisone Prednisone Proficient Rx LP ANDA Current 71205-421 Prednisone Prednisone Proficient Rx LP ANDA Current 71205-421 Prednisone Prednisone Proficient Rx LP ANDA Current 71205-421 Prednisone Prednisone Proficient Rx LP ANDA Current 71205-421 Prednisone Prednisone Proficient Rx LP ANDA Current 71205-421 Prednisone Prednisone Proficient Rx LP ANDA Current 71205-665 Prednisone Prednisone Proficient Rx LP ANDA Current 71335-1780 Prednisone Prednisone Bryant Ranch Prepack ANDA Current 71335-1780 Prednisone Prednisone Bryant Ranch Prepack ANDA Current 71335-2160 Prednisone Prednisone Bryant Ranch Prepack ANDA Current