Home Applications 211582 Application 211582
Type ANDA
Sponsor ZYDUS PHARMS USA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DAPAGLIFLOZIN DAPAGLIFLOZIN TABLET;ORAL 5MG No No 002 DAPAGLIFLOZIN DAPAGLIFLOZIN TABLET;ORAL 10MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A211582-001 DAPAGLIFLOZIN DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 A211582-002 DAPAGLIFLOZIN DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2026-04-06
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.
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 A211582-001 DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211582-002 DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2026-04-06 caaa826d4ba7…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211582-001 DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2022-02-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211582-002 DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2022-02-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211582-001 DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2022-02-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211582-002 DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2022-02-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211582-001 DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2022-02-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211582-002 DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2022-02-22 4b0b4de00fa7…2024-02-18 07:12 UTC 2024-02 A211582-001 DAPAGLIFLOZIN 5MG TABLET / ORAL 2022-02-22 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A211582-002 DAPAGLIFLOZIN 10MG TABLET / ORAL 2022-02-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211582-001 DAPAGLIFLOZIN 5MG TABLET / ORAL 2022-02-22 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A211582-002 DAPAGLIFLOZIN 10MG TABLET / ORAL 2022-02-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211582-001 DAPAGLIFLOZIN 5MG TABLET / ORAL 2022-02-22 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211582-002 DAPAGLIFLOZIN 10MG TABLET / ORAL 2022-02-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211582-001 DAPAGLIFLOZIN 5MG TABLET / ORAL 2022-02-22 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211582-002 DAPAGLIFLOZIN 10MG TABLET / ORAL 2022-02-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211582-001 DAPAGLIFLOZIN 5MG TABLET / ORAL 2022-02-22 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211582-002 DAPAGLIFLOZIN 10MG TABLET / ORAL 2022-02-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211582-001 DAPAGLIFLOZIN 5MG TABLET / ORAL 2022-02-22 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211582-002 DAPAGLIFLOZIN 10MG TABLET / ORAL 2022-02-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211582-001 DAPAGLIFLOZIN 5MG TABLET / ORAL 2022-02-22 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A211582-002 DAPAGLIFLOZIN 10MG TABLET / ORAL 2022-02-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211582-001 DAPAGLIFLOZIN 5MG TABLET / ORAL 2022-02-22 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A211582-002 DAPAGLIFLOZIN 10MG TABLET / ORAL 2022-02-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211582-001 DAPAGLIFLOZIN 5MG TABLET / ORAL 2022-02-22 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211582-002 DAPAGLIFLOZIN 10MG TABLET / ORAL 2022-02-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211582-001 DAPAGLIFLOZIN 5MG TABLET / ORAL 2022-02-22 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A211582-002 DAPAGLIFLOZIN 10MG TABLET / ORAL 2022-02-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211582-001 DAPAGLIFLOZIN 5MG TABLET / ORAL 2022-02-22 e64feba35796…2022-09-29 23:25 UTC 2022-09 A211582-002 DAPAGLIFLOZIN 10MG TABLET / ORAL 2022-02-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211582-001 DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2022-02-22 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211582-002 DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2022-02-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211582-001 DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211582-002 DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2026-04-06 a50c72e98297…
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 · 2 matching rows.
Documents# Document, Submission type, Date table Document Submission type Date 65508 ORIG 2020-12-07