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 1 .
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 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# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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