Home Applications 211563 Application 211563
Type ANDA
Sponsor ALKEM LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;500MG No No 002 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;1GM No No 003 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;500MG No No 004 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;1GM No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211563-001 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 A211563-002 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 A211563-003 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 A211563-004 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 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 2026-09-14 22:38:34 2026-08 A211563-001 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211563-002 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211563-003 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211563-004 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211563-001 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211563-002 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211563-003 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211563-004 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211563-001 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211563-002 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211563-003 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211563-004 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity 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 · 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 63028 ORIG 2020-05-15