FDA.reportPublic FDA data

Application 078422

Type
ANDA
Sponsor
IPCA LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET;ORAL500MGNoNo
002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET;ORAL850MGNoNo
003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET;ORAL1GMNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078422-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET / ORAL2007-08-06
A078422-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE850MGTABLET / ORAL2007-08-06
A078422-003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET / ORAL2007-08-06

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078422-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2007-08-0684e616aacf4f…
2026-09-14 22:38:342026-08A078422-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2007-08-0684e616aacf4f…
2026-09-14 22:38:342026-08A078422-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2007-08-0684e616aacf4f…
2026-08-18 06:07:402026-07A078422-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2007-08-06caaa826d4ba7…
2026-08-18 06:07:402026-07A078422-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2007-08-06caaa826d4ba7…
2026-08-18 06:07:402026-07A078422-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2007-08-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078422-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2007-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078422-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2007-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078422-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2007-08-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078422-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2007-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078422-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2007-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078422-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2007-08-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A078422-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2007-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078422-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2007-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078422-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2007-08-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078422-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2007-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078422-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2007-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078422-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2007-08-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078422-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2007-08-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078422-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2007-08-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078422-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2007-08-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078422-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2007-08-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078422-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2007-08-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078422-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2007-08-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078422-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2007-08-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078422-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2007-08-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078422-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2007-08-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078422-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2007-08-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078422-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2007-08-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078422-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2007-08-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078422-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2007-08-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078422-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2007-08-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078422-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2007-08-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078422-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2007-08-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A078422-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2007-08-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A078422-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2007-08-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078422-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2007-08-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078422-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2007-08-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078422-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2007-08-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078422-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2007-08-06301d65b070ca…

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 5 of 14 · 261 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs0448c618-2f0d-4ed3-866f-74b413cf902d2026-04-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPrecision Dose, Inc.60142fb2-16da-4f54-a542-74f9a70b9c8b2026-04-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC388ee1e0-a0d2-324d-e063-6394a90a16642026-03-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride Oral SolutionMETFORMIN HYDROCHLORIDEMICRO LABS LIMITEDfb90693a-074a-45be-94f4-ed6298b1f4e42026-03-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.abd0dad9-5f29-4102-a099-dce7bdddb98b2026-03-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochlorideMETFORMIN HYDROCHLORIDELegacy Pharmaceutical Packaging, LLCb51da8d7-ab4a-4c40-97c9-88bd379366d12026-03-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin hydrochloride
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEdirect rxc33e24e9-0441-6b94-e053-2a95a90a9c682026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions75b25738-31e6-4b58-9d2b-f4a1ab4ab0902026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride Oral SolutionMETFORMIN HYDROCHLORIDEBionpharma Inc.,3ab005d4-bc99-4fdb-e063-6394a90a51242026-02-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMethod Pharmaceuticals, LLC.4aa880a4-7ec0-9155-e063-6394a90a8f3e2026-02-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions239834b0-121a-4903-b3ee-90bb4db4753b2026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions5f2023d2-05ae-489d-9e18-fb75057496bc2026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions1d7556eb-82b4-4085-b0b1-dc061b216feb2026-02-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEGLENMARK PHARMACEUTICALS INC., USA0ef9de1a-b786-4b6c-a250-3f5ac532b16a2026-01-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEQuallent Pharmaceuticals Health LLC6864ff5a-7512-4a4f-ad26-b2b9c58434142026-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions8c248958-6c01-455e-89f5-959facb272ed2026-01-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsf59ceea4-a84a-4082-8e73-7c6f340c28d62026-01-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions192970d3-826a-4b69-a525-9742794dc19c2026-01-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Incdfac4d9c-2f20-417c-a1be-4f1c2738f3512026-01-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC273d86b0-9d30-48c9-8918-c5e1ececa9512026-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.