Home Applications 083677 Application 083677
Type ANDA
Sponsor MYLAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PREDNISONE PREDNISONE TABLET;ORAL 20MG No No 002 PREDNISONE PREDNISONE TABLET;ORAL 5MG No No 003 PREDNISONE PREDNISONE TABLET;ORAL 10MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A083677-001 PREDNISONE PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 A083677-002 PREDNISONE PREDNISONE 5MG TABLET / ORAL AB Approved before 1982 A083677-003 PREDNISONE PREDNISONE 10MG TABLET / ORAL AB 1985-12-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 2 · 56 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 2026-10-15 13:18:30 2026-09 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 A083677-002 PREDNISONE 5MG TABLET / ORAL AB Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 A083677-003 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 c2088c7a36db…2026-09-14 22:38:34 2026-08 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A083677-002 PREDNISONE 5MG TABLET / ORAL AB Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A083677-003 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A083677-002 PREDNISONE 5MG TABLET / ORAL AB Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A083677-003 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A083677-002 PREDNISONE 5MG TABLET / ORAL AB Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A083677-003 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083677-002 PREDNISONE 5MG TABLET / ORAL AB Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083677-003 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A083677-001 PREDNISONE 20MG TABLET / ORAL AB Approved before 1982 ea99ee380514…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 56 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Prednisone PREDNISONE Golden State Medical Supply, Inc. 1e05e071-0407-0970-e063-6294a90a6c65 2025-02-18 Warnings, Adverse reactions Exact identifier application applno (ANDA): 083677 application number: ANDA083677
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 · 35 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0143-9738 Prednisone Prednisone West-ward Pharmaceuticals Corp ANDA Current 0143-9738 Prednisone Prednisone West-ward Pharmaceuticals Corp ANDA Current 0143-9738 Prednisone Prednisone West-ward Pharmaceuticals ANDA Current 0378-0642 Prednisone Prednisone Mylan Pharmaceuticals Inc. ANDA Current 0378-0642 Prednisone Prednisone Mylan Pharmaceuticals Inc. ANDA Current 0378-0642 Prednisone Prednisone Mylan Pharmaceuticals Inc. ANDA Current 0378-0642 Prednisone Prednisone Mylan Pharmaceuticals Inc. ANDA Current 0378-0642 Prednisone Prednisone Mylan Pharmaceuticals Inc ANDA Current 0440-8167 Prednisone Prednisone Liberty Pharmaceuticals, Inc. ANDA Current 10544-473 Prednisone Prednisone Blenheim Pharmacal, Inc. ANDA Current 10544-509 Prednisone Prednisone Blenheim Pharmacal, Inc. ANDA Current 12634-188 Prednisone Prednisone Apotheca Inc. ANDA Current 21695-307 Prednisone Prednisone Rebel Distributors Corp ANDA Current 50090-0099 Prednisone Prednisone A-S Medication Solutions ANDA Current 50090-0100 Prednisone Prednisone A-S Medication Solutions ANDA Current 50090-0101 Prednisone Prednisone A-S Medication Solutions ANDA Current 50436-4326 Prednisone Prednisone Unit Dose Services ANDA Current 53217-288 Prednisone Prednisone Aidarex Pharmaceuticals LLC ANDA Current 53808-0399 Prednisone PREDNISONE State of Florida DOH Central Pharmacy ANDA Current 59115-141 Prednisone Prednisone Hikma Pharmaceutical ANDA Current 61919-342 PREDNISONE PREDNISONE DirectRX ANDA Current 61919-342 Prednisone Prednisone DIRECT RX ANDA Current 61919-342 PREDNISONE PREDNISONE Direct_Rx ANDA Current 61919-342 PREDNISONE PREDNISONE Direct_Rx ANDA Current 63187-085 Prednisone Prednisone Proficient Rx LP ANDA Current 63187-085 Prednisone Prednisone Proficient Rx LP ANDA Current 67296-0974 Prednisone Prednisone RedPharm Drug, Inc. ANDA Current 67296-0974 Prednisone Prednisone RedPharm Drug, Inc. ANDA Current 67296-0974 Prednisone Prednisone RedPharm Drug, Inc. ANDA Current 68387-240 Prednisone PREDNISONE Keltman Pharmaceuticals Inc. ANDA Current 68387-241 Prednisone PREDNISONE Keltman Pharmaceuticals Inc. ANDA Current 69668-120 Deltasone Prednisone Oculus Innovative Sciences ANDA Current 70518-0205 Prednisone Prednisone REMEDYREPACK INC. ANDA Current 70518-0800 Prednisone Prednisone REMEDYREPACK INC. ANDA Current 70518-0800 Prednisone Prednisone REMEDYREPACK INC. ANDA Current