Home Applications 205980 Application 205980
Type ANDA
Sponsor MYLAN PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SAXAGLIPTIN SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE No No 002 SAXAGLIPTIN HYDROCHLORIDE SAXAGLIPTIN HYDROCHLORIDE TABLET; ORAL EQ 2.5MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205980-001 SAXAGLIPTIN SAXAGLIPTIN HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 A205980-002 SAXAGLIPTIN SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 44 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 2026-09-14 22:38:34 2026-08 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 71904 ORIG 2022-08-26