Home Applications 211583 Application 211583
Type ANDA
Sponsor TEVA PHARMS USA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 2.5MG/1000MG No No 002 DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG/500MG No No 003 DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG/1000MG No No 004 DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG/500MG No No 005 DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG/1000MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211583-001 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 2.5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 A211583-002 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 A211583-003 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 A211583-004 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 A211583-005 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 · 5 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 A211583-001 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 2.5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211583-002 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211583-003 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211583-004 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211583-005 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211583-001 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 2.5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211583-002 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211583-003 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211583-004 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211583-005 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 A211583-001 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 2.5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211583-002 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 A211583-003 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 A211583-004 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 A211583-005 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 a50c72e98297…
Observed Orange Book normalized TE history# 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 72027 ORIG 2022-09-07