Application 202306

Type
ANDA
Sponsor
INTELLIPHARMACEUTICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL500MGNoNo
002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL750MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A202306-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-23
A202306-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202306-001AB1
A202306-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202306-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-23caaa826d4ba7…
2026-08-18 06:07:402026-07A202306-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202306-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202306-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202306-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202306-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A202306-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202306-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202306-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202306-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202306-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202306-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202306-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202306-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202306-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202306-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202306-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202306-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202306-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202306-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202306-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A202306-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202306-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202306-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202306-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202306-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202306-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202306-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202306-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202306-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202306-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202306-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202306-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202306-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202306-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202306-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202306-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202306-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202306-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12017-02-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202306-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2017-02-23bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202306-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A202306-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202306-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202306-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202306-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202306-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202306-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202306-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202306-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202306-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202306-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202306-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202306-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202306-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202306-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202306-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202306-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202306-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202306-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202306-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202306-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A202306-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202306-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202306-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202306-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202306-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202306-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202306-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202306-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202306-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202306-001AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202306-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202306-001AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202306-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202306-001AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202306-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202306-001AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202306-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202306-001AB11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202306-002AB1bb7c543d1eb4…

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 · 269 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.583f2a2e-a9d7-f266-e063-6294a90ad0ab2026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1d0b74de-ef4c-4dd2-8019-2ddb409c60b42026-08-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.59a4ccda-5487-4ac4-9373-0c0fc8b7c88b2026-08-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEProficient Rx LPd8bd1779-d1c4-4dde-816d-ea72b37bb5cd2026-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f55a245b-a786-4a4a-b11c-c61d48294b012026-07-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.41408f64-d366-403e-9595-464ab25c6f972026-07-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.68d0b1a6-c99e-42cf-afdf-b71ee73c44242026-07-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.9171d369-d35a-40e4-a9ad-26484e66fc5e2026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METFORMIN HYDROCHLORIDE
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.30658e19-8e6e-49aa-a007-e414224797c52026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.1503bbe4-0ac5-479b-9900-d38e49236bf02026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metformin Hydrochloride
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECardinal Health 107, LLC46cb7e3f-c739-433d-9dbe-427c2d95bef12026-07-24Boxed 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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
35208-001Metformin HydrochlorideMetformin HydrochlorideIntelliPharmaCeutics Corp.ANDACurrent
35208-001Metformin HydrochlorideMetformin HydrochlorideIntelliPharmaCeutics Corp.ANDACurrent
35208-002Metformin HydrochlorideMetformin HydrochlorideIntelliPharmaCeutics Corp.ANDACurrent
35208-002Metformin HydrochlorideMetformin HydrochlorideIntelliPharmaCeutics Corp.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47415ORIG2017-03-02