Home Applications 079118 Application 079118
Type ANDA
Sponsor AUROBINDO PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG No No 002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A079118-001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB1 2012-07-20 A079118-002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE / ORAL AB 2012-07-20
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 3 of 3 · 88 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 2022-10-28 04:53 UTC 2022-10 A079118-001 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB1 2012-07-20 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A079118-002 METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE / ORAL AB 2012-07-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079118-001 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB1 2012-07-20 e64feba35796…2022-09-29 23:25 UTC 2022-09 A079118-002 METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE / ORAL AB 2012-07-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A079118-001 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB1 2012-07-20 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A079118-002 METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE / ORAL AB 2012-07-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A079118-001 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB1 2012-07-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A079118-002 METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE / ORAL AB 2012-07-20 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 57237-210 Metformin Hydrochloride Metformin Hydrochloride Citron Pharma LLC ANDA Current 57237-211 Metformin Hydrochloride Metformin Hydrochloride Citron Pharma LLC ANDA Current 65862-291 Metformin Hydrochloride Metformin Hydrochloride Aurobindo Pharma Limited ANDA Current 65862-291 Metformin Hydrochloride Metformin Hydrochloride Aurobindo Pharma Limited ANDA Current 65862-291 Metformin Hydrochloride Metformin Hydrochloride Aurobindo Pharma Limited ANDA Current 65862-291 Metformin Hydrochloride Metformin Hydrochloride Aurobindo Pharma Limited ANDA Current 65862-291 Metformin Hydrochloride Metformin Hydrochloride Aurobindo Pharma Limited ANDA Current 65862-292 Metformin Hydrochloride Metformin Hydrochloride Aurobindo Pharma Limited ANDA Current 65862-292 Metformin Hydrochloride Metformin Hydrochloride Aurobindo Pharma Limited ANDA Current 65862-292 Metformin Hydrochloride Metformin Hydrochloride Aurobindo Pharma Limited ANDA Current 65862-292 Metformin Hydrochloride Metformin Hydrochloride Aurobindo Pharma Limited ANDA Current 65862-292 Metformin Hydrochloride Metformin Hydrochloride Aurobindo Pharma Limited ANDA Current