Application 203755

Type
ANDA
Sponsor
ACTAVIS LABS FL INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203755-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-01
A203755-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203755-001AB3
A203755-002AB3

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203755-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-0184e616aacf4f…
2026-09-14 22:38:342026-08A203755-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-0184e616aacf4f…
2026-08-18 06:07:402026-07A203755-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-01caaa826d4ba7…
2026-08-18 06:07:402026-07A203755-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203755-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203755-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203755-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203755-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203755-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203755-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203755-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203755-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203755-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203755-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203755-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203755-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203755-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203755-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203755-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203755-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203755-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203755-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203755-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A203755-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203755-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203755-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203755-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203755-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203755-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203755-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203755-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203755-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203755-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203755-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203755-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203755-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203755-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203755-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203755-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB32016-08-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203755-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB32016-08-0174a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203755-001AB3184e616aacf4f…
2026-09-14 22:38:342026-08A203755-002AB3184e616aacf4f…
2026-08-18 06:07:402026-07A203755-001AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A203755-002AB31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203755-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203755-002AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203755-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203755-002AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203755-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203755-002AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203755-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203755-002AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203755-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203755-002AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203755-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203755-002AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203755-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203755-002AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203755-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203755-002AB315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203755-001AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203755-002AB31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203755-001AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A203755-002AB31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203755-001AB3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203755-002AB3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203755-001AB31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203755-002AB31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203755-001AB311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203755-002AB311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203755-001AB318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203755-002AB318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203755-001AB315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203755-002AB315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203755-001AB315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203755-002AB315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203755-001AB314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203755-002AB314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203755-001AB3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203755-002AB3174a2ff9319b5…

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 14 · 274 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.d5228e81-9c86-4781-b984-20feaa2ae7792026-09-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECamber Pharmaceuticals, Inc.7cc02a26-5c22-445b-ad8f-3e7570c143d32026-09-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEGranules India Ltd73197cb5-3e23-4ac0-b189-f9bc848bce662026-09-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutionsb6d7edc9-93d6-4480-906d-55c18d0536002026-09-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
GlumetzaMETFORMIN HYDROCHLORIDESantarus, Inc.fb832474-88d9-4e29-95cd-fbc446944cc42026-09-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions64f5b140-7ad8-4c07-bbfc-ae4618afa8502026-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.bfd6ec0f-8264-4877-aa6d-f347f53bc4262026-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.c568d49f-c040-4f1e-ad36-77b05ab659c32026-08-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.ba0379cb-824e-4798-9ff9-99bcd1bea5cb2026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackfb296500-55cb-45ce-be0c-59aa2e3d46242026-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEScieGen Pharmaceuticals Inc4e4c4ba9-65c6-4273-8f6b-2423ab521dad2026-08-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.073cf6d9-7142-4d8b-898e-174c62a1f76f2026-08-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEQPharma,Inc.5866ca12-a28f-cbe7-e063-6294a90acc692026-08-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEQuallent Pharmaceuticals Health LLC25be863d-490c-47f6-9ad3-c828dc43fbf02026-08-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDERedpharm Drug58bec665-b648-6baf-e063-6394a90a1cbb2026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.e22a8545-86a6-439e-a758-29c4d6ed8bfe2026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackc1bfc7b5-c7e0-4353-b772-05d463c128862026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa2026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.4d087f00-580b-4b9d-80d9-f97930153e722026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.5d8d654a-9bb4-4c87-ab43-c21c4e8747082026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-2411Metformin HydrochlorideMetformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2411Metformin HydrochlorideMetformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2411Metformin HydrochlorideMetformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2412Metformin HydrochlorideMetformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2412Metformin HydrochlorideMetformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2412Metformin HydrochlorideMetformin HydrochlorideActavis Pharma, Inc.ANDACurrent
42291-558Metformin HydrochlorideMetformin HydrochlorideAvKARE, Inc.ANDACurrent
42291-558Metformin HydrochlorideMetformin HydrochlorideAvKAREANDACurrent
42291-559Metformin HydrochlorideMetformin HydrochlorideAvKARE, Inc.ANDACurrent
42291-559Metformin HydrochlorideMetformin HydrochlorideAvKAREANDACurrent
70518-0973Metformin HydrochlorideMetformin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0973Metformin HydrochlorideMetformin HydrochlorideREMEDYREPACK INC.ANDACurrent