FDA.reportPublic FDA data

Application 075961

Type
ANDA
Sponsor
WATSON LABS FLORIDA

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
A075961-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-25
A075961-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-25
A075961-003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-25

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 22:38:342026-08A075961-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-2584e616aacf4f…
2026-09-14 22:38:342026-08A075961-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-2584e616aacf4f…
2026-09-14 22:38:342026-08A075961-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-2584e616aacf4f…
2026-08-18 06:07:402026-07A075961-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-25caaa826d4ba7…
2026-08-18 06:07:402026-07A075961-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-25caaa826d4ba7…
2026-08-18 06:07:402026-07A075961-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075961-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075961-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075961-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075961-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075961-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075961-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A075961-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075961-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075961-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075961-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075961-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075961-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075961-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075961-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075961-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075961-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075961-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075961-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075961-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075961-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075961-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075961-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075961-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075961-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075961-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075961-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075961-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075961-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A075961-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A075961-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075961-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075961-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075961-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075961-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-25301d65b070ca…

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 8 of 13 · 251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDETIME CAP LABORATORIES, INC1d8b8970-c2a1-4780-be87-ab8ccfd401fa2025-06-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions0cd086d6-3ae2-476e-b93e-29055e67e8fc2025-06-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutionsa434b937-2648-4509-8ce8-94a28582ec772025-06-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions784a6bbd-4f13-45ed-89c1-154b06721ed02025-06-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsf6581ce6-0f9f-4887-ae83-4c6ecde619f32025-06-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions9fed67ea-7a15-4634-80cf-c975b8812ebe2025-06-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions2d68fd88-c591-4577-a7c3-901338bdaf902025-06-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepack52eecdbd-e07e-447f-bf38-b3c347b606622025-06-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDECoupler LLC33ec9f6e-16d9-40ba-e063-6294a90ae87b2025-04-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.103080cb-6381-44f6-8a31-1fc81e7c890f2025-04-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.33155746-c2ef-12f4-e063-6294a90a039c2025-04-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDETAGI Pharma, Inc.dd0ee2bf-f658-42dc-976d-49af0b1f32b52025-04-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECoupler, LLC32ff33ed-89ed-c391-e063-6294a90ae4142025-04-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEBryant Ranch Prepackd7c1ff9e-4faa-4f65-9c87-e8108499791f2025-03-28WarningsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack3e55944a-ed5b-4892-804f-abbe15b0d70c2025-03-28WarningsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackde4a660b-172b-4c72-9e38-5634fd03cfa72025-03-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDECoupler LLC2d7d9364-e71d-4ef6-e063-6394a90af8412025-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack4db5551b-04f6-4921-9dee-68acb41f7f712025-02-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.0865f83f-0f34-0690-e063-6294a90abf042025-02-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.0b3d5420-d60c-8385-e063-6394a90abb6c2025-02-03Boxed 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.