Application 212595

Type
NDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIOMET ERMETFORMIN HYDROCHLORIDEFOR SUSPENSION, EXTENDED RELEASE;ORAL500MG/5MLYesYes

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

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
N212595-001RIOMET ERMETFORMIN HYDROCHLORIDE500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-29

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N212595-00199623362035-05-01Drug product2019-09-05

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-2984e616aacf4f…
2026-08-18 06:07:402026-07N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD, RS2019-08-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD, RS2019-08-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD, RS2019-08-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD, RS2019-08-293f01610625f2…
2019-09-15 20:21 UTC2019-09N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD, RS2019-08-29b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N212595-001RIOMET ER500MG/5MLFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2019-08-29e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N212595-00199623362035-05-01Drug product2019-09-0584e616aacf4f…
2026-08-18 06:07:402026-07N212595-00199623362035-05-01Drug product2019-09-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N212595-00199623362035-05-01Drug product2019-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212595-00199623362035-05-01Drug product2019-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N212595-00199623362035-05-01Drug product2019-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212595-00199623362035-05-01Drug product2019-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212595-00199623362035-05-01Drug product2019-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212595-00199623362035-05-01Drug product2019-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212595-00199623362035-05-01Drug product2019-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212595-00199623362035-05-01Drug product2019-09-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212595-00199623362035-05-01Drug product2019-09-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N212595-00199623362035-05-01Drug product2019-09-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N212595-00199623362035-05-01Drug product2019-09-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N212595-00199623362035-05-01Drug product2019-09-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N212595-00199623362035-05-01Drug product2019-09-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N212595-00199623362035-05-01Drug product2019-09-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N212595-00199623362035-05-01Drug product2019-09-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N212595-00199623362035-05-01Drug product2019-09-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N212595-00199623362035-05-01Drug product2019-09-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N212595-00199623362035-05-01Drug product2019-09-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N212595-00199623362035-05-01Drug product2019-09-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N212595-00199623362035-05-01Drug product2019-09-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N212595-00199623362035-05-01Drug product2019-09-0587673890dc5c…
2021-03-12 10:30 UTC2021-03N212595-00199623362035-05-01Drug product2019-09-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N212595-00199623362035-05-01Drug product2019-09-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11N212595-00199623362035-05-01Drug product2019-09-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12N212595-00199623362035-05-01Drug product2019-09-053f01610625f2…
2019-09-15 20:21 UTC2019-09N212595-00199623362035-05-01Drug product2019-09-05b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N212595-00199623362035-05-01Drug product2019-09-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N212595-00199623362035-05-01Drug product2019-09-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12N212595-00199623362035-05-01Drug product2019-09-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N212595-00199623362035-05-01Drug product2019-09-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N212595-00199623362035-05-01Drug product2019-09-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N212595-00199623362035-05-01Drug product2019-09-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N212595-00199623362035-05-01Drug product2019-09-053f0d92c62455…
2023-05-13 08:27 UTC2023-05N212595-00199623362035-05-01Drug product2019-09-05053a50430f4f…
2023-01-26 05:58 UTC2023-01N212595-00199623362035-05-01Drug product2019-09-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N212595-00199623362035-05-01Drug product2019-09-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N212595-00199623362035-05-01Drug product2019-09-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N212595-00199623362035-05-01Drug product2019-09-05e64feba35796…

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 3 of 13 · 253 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMARKSANS PHARMA LIMITEDd09a2eda-fdd8-44ed-8e2f-ea91ddfd3c682026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEUnit Dose Solutions, Inc.552ad61d-bafd-478d-e063-6294a90a02f92026-06-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEMarlex Pharmaceuticals, Inc.3d6f397b-e909-bee9-e063-6294a90aba172026-06-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEViona Pharmaceuticals Inc85027e6c-d35b-49eb-a234-dd71aa77aee02026-06-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.41a8bb80-7b0b-476c-8134-5d161c3239c82026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAurobindo Pharma Limited8d4b8620-5e99-4d12-b4f2-e9967b627b572026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMajor Pharmaceuticals5e783025-bf6d-465e-bf58-bcd253afad2c2026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.4182bcf0-1f9a-4f3a-9428-86b5d757954f2026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.62ca8af4-ff91-4bf6-b7c6-895b3b5ce8c32026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.14450912-54b5-4fc3-ba65-77ece864b2e72026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.902d1bc4-3f1f-4a1a-86d7-cf98c56a36842026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.33550b88-d4bb-4ce6-a7db-07c966f6984f2026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals, Inc.14238afd-200d-4a05-b731-647c43cecbc32026-06-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.104b5f5b-cc83-450d-82ec-1fd20c4f71192026-06-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepack11d52559-bfde-4c2a-9602-f18fb31876172026-06-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsf4fc759a-057e-4b5d-b8ab-13bc5eeb24e42026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions400ff9dc-9789-44ac-afb5-730b632a16672026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutionsc0ff557c-fa50-46f6-aa77-36a4df354e802026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions4f5389d2-dbcf-4fcb-9048-05953eb1fb052026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepack4d245bc3-0add-4651-b441-86b93c5ac6812026-06-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10631-019RIOMET ERMetformin HydrochlorideSun Pharmaceutical Industries Inc.NDACurrent
10631-019RIOMET ERMetformin HydrochlorideSun Pharmaceutical Industries Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61864ORIG2020-02-11
59886ORIG2019-08-30
59880ORIG2019-08-30
63143ORIG1900-01-01
63142ORIG1900-01-01