Home Applications 020682 Application 020682
Type NDA
Sponsor PHARMACIA AND UPJOHN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GLYSET MIGLITOL TABLET;ORAL 25MG Yes Yes 002 GLYSET MIGLITOL TABLET;ORAL 50MG Yes No 003 GLYSET MIGLITOL TABLET;ORAL 100MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N020682-001 GLYSET MIGLITOL 25MG TABLET / ORAL RLD 1996-12-18 N020682-002 GLYSET MIGLITOL 50MG TABLET / ORAL RLD 1996-12-18 N020682-003 GLYSET MIGLITOL 100MG TABLET / ORAL RLD 1996-12-18
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 4 · 123 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 N020682-001 GLYSET 25MG TABLET / ORAL RLD 1996-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020682-002 GLYSET 50MG TABLET / ORAL RLD 1996-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020682-003 GLYSET 100MG TABLET / ORAL RLD 1996-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020682-001 GLYSET 25MG TABLET / ORAL RLD 1996-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020682-002 GLYSET 50MG TABLET / ORAL RLD 1996-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020682-003 GLYSET 100MG TABLET / ORAL RLD 1996-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 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 · 2 matching rows.
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 0009-5012 Glyset miglitol Pharmacia and Upjohn Company LLC NDA Current 0009-5012 Glyset miglitol Pharmacia & Upjohn Company LLC NDA Current 0009-5012 Glyset miglitol Pharmacia and Upjohn Company LLC NDA Current 0009-5013 Glyset miglitol Pharmacia and Upjohn Company LLC NDA Current 0009-5013 Glyset miglitol Pharmacia & Upjohn Company LLC NDA Current 0009-5013 Glyset miglitol Pharmacia and Upjohn Company LLC NDA Current 0009-5014 Glyset miglitol Pharmacia and Upjohn Company LLC NDA Current 0009-5014 Glyset miglitol Pharmacia & Upjohn Company LLC NDA Current 0009-5014 Glyset miglitol Pharmacia and Upjohn Company LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 57686 ORIG 2019-02-15 25499 SUPPL 2012-09-20 13188 SUPPL 2012-09-17 35127 SUPPL 2009-05-13 25498 SUPPL 2009-05-04 41544 SUPPL 1999-08-16 3064 SUPPL 1999-08-16