Home Applications 078170 Application 078170
Type ANDA
Sponsor GLENMARK GENERICS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG No No 002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG No No 003 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078170-001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2008-05-23 A078170-002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2008-05-23 A078170-003 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2008-05-23
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 1 of 4 · 129 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 2026-09-14 22:38:34 2026-08 A078170-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2008-05-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078170-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2008-05-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078170-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2008-05-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078170-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2008-05-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078170-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2008-05-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078170-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2008-05-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078170-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2008-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078170-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2008-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078170-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2008-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078170-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2008-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078170-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2008-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078170-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2008-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078170-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2008-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078170-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2008-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078170-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2008-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078170-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2008-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078170-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2008-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078170-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2008-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078170-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2008-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078170-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2008-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078170-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2008-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078170-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2008-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078170-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2008-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078170-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2008-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078170-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2008-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078170-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2008-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078170-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2008-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078170-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2008-05-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078170-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2008-05-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078170-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2008-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078170-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2008-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078170-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2008-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078170-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2008-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078170-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2008-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078170-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2008-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078170-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2008-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078170-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2008-05-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078170-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2008-05-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078170-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2008-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078170-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2008-05-23 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 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 14 of 14 · 261 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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 53808-0381 Metformin Hydrochloride Metformin Hydrochloride State of Florida DOH Central Pharmacy ANDA Current 53808-0712 Metformin Hydrochloride Metformin Hydrochloride State of Florida DOH Central Pharmacy ANDA Current 53808-0717 Metformin Hydrochloride Metformin Hydrochloride State of Florida DOH Central Pharmacy ANDA Current 68462-159 Metformin Hydrochloride Metformin Hydrochloride Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-160 Metformin Hydrochloride Metformin Hydrochloride Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-161 Metformin Hydrochloride Metformin Hydrochloride Glenmark Pharmaceuticals Inc., USA ANDA Current