Application 201991

Type
ANDA
Sponsor
INVENTIA

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201991-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201991-001AB1

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-183f01610625f2…
2019-09-15 20:21 UTC2019-09A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201991-001AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201991-001AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201991-001AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201991-001AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201991-001AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201991-001AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201991-001AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201991-001AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201991-001AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201991-001AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201991-001AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201991-001AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201991-001AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201991-001AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201991-001AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201991-001AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201991-001AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201991-001AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201991-001AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201991-001AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201991-001AB1187673890dc5c…
2021-03-12 10:30 UTC2021-03A201991-001AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201991-001AB118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201991-001AB11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201991-001AB113f01610625f2…
2019-09-15 20:21 UTC2019-09A201991-001AB11b00525d2431f…
2019-07-19 19:46 UTC2019-07A201991-001AB11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201991-001AB116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201991-001AB111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201991-001AB11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201991-001AB11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201991-001AB119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201991-001AB11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201991-001AB113f0d92c62455…
2023-05-13 08:27 UTC2023-05A201991-001AB11053a50430f4f…
2023-01-26 05:58 UTC2023-01A201991-001AB113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201991-001AB113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201991-001AB11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201991-001AB11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201991-001AB11cb3db0bc1861…

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 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.9171d369-d35a-40e4-a9ad-26484e66fc5e2026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
METFORMIN HYDROCHLORIDE ERMETFORMIN HYDROCHLORIDELeading Pharma, LLC3dca884d-ec44-496f-9eeb-31fd8fa3f5742026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAscend Laboratories, LLCa944a167-e3ac-4084-af1c-22b48713471c2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
ndc (product): 67877-159
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEQPharma Inc5269e91f-7e93-9405-e063-6294a90a32172026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
Metformin hydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP3ba957ea-28ed-4a61-a318-98064ea4944d2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
ndc (product): 63187-779
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENorthwind Health Company, LLC07d8a69f-30d9-7511-e063-6394a90a95ca2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
Metformin hydrochlorideMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.4be72741-4f6d-6689-e054-00144ff8d46c2025-09-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
ndc (product): 68071-1419
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepackf2318509-9a49-4c99-a08b-22381f17aacd2025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
ndc (product): 71335-0886
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f55a245b-a786-4a4a-b11c-c61d48294b012025-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions0cd086d6-3ae2-476e-b93e-29055e67e8fc2025-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
ndc (product): 50090-1494
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutionsa434b937-2648-4509-8ce8-94a28582ec772025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions784a6bbd-4f13-45ed-89c1-154b06721ed02025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.4adeddf2-f449-4a61-9658-dfbff7c502302025-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs5bb945c1-954a-4d43-aa24-33767d19c57c2024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
ndc (product): 0615-8289
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC1a047fc0-196e-79af-e063-6394a90a1e0d2024-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8289METFORMIN HYDROCHLORIDEmetformin hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8289METFORMIN HYDROCHLORIDEmetformin hydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0781-5503METFORMIN HYDROCHLORIDEmetformin hydrochlorideSANDOZ INC.ANDACurrent
10544-944Metformin hydrochlorideMetformin hydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
49252-001Metformin hydrochlorideMetformin hydrochlorideInventia Healthcare Private LimitedANDACurrent
50090-1494METFORMIN HYDROCHLORIDEmetformin hydrochlorideA-S Medication SolutionsANDACurrent
50090-1494METFORMIN HYDROCHLORIDEmetformin hydrochlorideA-S Medication SolutionsANDACurrent
55700-618METFORMIN HYDROCHLORIDEmetformin hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-450METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEDIRECT RXANDACurrent
61919-450METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEDirect_RxANDACurrent
61919-769METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEDirectRXANDACurrent
63187-779Metformin hydrochlorideMetformin hydrochlorideProficient Rx LPANDACurrent
63187-779Metformin hydrochlorideMetformin hydrochlorideProficient Rx LPANDACurrent
67296-1643METFORMIN HYDROCHLORIDEmetformin hydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1643METFORMIN HYDROCHLORIDEmetformin hydrochlorideRedPharm Drug, Inc.ANDACurrent
67877-159METFORMIN HYDROCHLORIDEmetformin hydrochlorideAscend Laboratories, LLCANDACurrent
67877-159METFORMIN HYDROCHLORIDEmetformin hydrochlorideAscend Laboratories, LLCANDACurrent
68071-1419Metformin hydrochlorideMetformin hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2636METFORMIN HYDROCHLORIDEmetformin hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6780Metformin hydrochlorideMetformin hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0408METFORMIN HYDROCHLORIDEmetformin hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3260METFORMIN HYDROCHLORIDEmetformin hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3260METFORMIN HYDROCHLORIDEmetformin hydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0886METFORMIN HYDROCHLORIDEmetformin hydrochlorideBryant Ranch PrepackANDACurrent
71335-0886METFORMIN HYDROCHLORIDEmetformin hydrochlorideBryant Ranch PrepackANDACurrent
71335-0886METFORMIN HYDROCHLORIDEmetformin hydrochlorideBryant Ranch PrepackANDACurrent
71610-457METFORMIN HYDROCHLORIDEmetformin hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-457METFORMIN HYDROCHLORIDEmetformin hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
75834-500METFORMIN HYDROCHLORIDEmetformin hydrochlorideNivagen Pharmaceuticals IncANDACurrent
75834-500Metformin hydrochlorideMetformin hydrochlorideNivagen Pharmaceuticals IncANDACurrent