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 11 of 13 · 253 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions1a7f7ef3-a94b-4ff6-a9f2-f5de4a99c7f62024-04-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsafb183f6-a13c-4f00-82d5-9fe336173d342024-04-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepackd5dbf0d9-9673-4aae-9e28-da9b90bac0382024-03-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsc2783b59-7b20-4d4c-a3ca-03ed60dcf2c32024-03-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions2be73d5e-7682-4ad3-831b-8c1ea73e38de2024-03-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP928ef685-80cb-42a9-a155-3c21c9b1dd672024-03-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.1182bf60-3578-a0ed-e063-6394a90aa50f2024-02-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack9c33414b-5dbb-4ce9-910b-9480d45e50ee2024-02-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepackf9e78e0f-6a0a-4db3-bc09-5500748f9c842024-02-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions3c607f04-d36f-4cf8-9cc9-7f2af08b40982024-01-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions7cc82387-8bb0-4bee-9967-cb13eab1d8012024-01-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCb090b18b-b53c-4c92-892f-d11551cfedc32023-12-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC38687872-ca68-4965-b317-637c25ba041e2023-11-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsd0bc43a4-301f-4002-9b58-bd81dddf27902023-10-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsa4679179-af2d-4c84-a1c8-ab0870a4585d2023-10-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEVGYAAN Pharmaceuticals LLC129ff158-097f-401a-8924-d9258465c1f32023-09-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsd60139c2-fd35-4ab4-af7e-7410481edc2e2023-09-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP1b9b6db9-1bac-4252-a03c-18dc0271f05f2023-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack88af3365-1145-45a1-ab0f-1c794f0c13db2023-05-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride ERMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC1ebaab3a-3d62-4c36-853f-c8784993eafb2023-04-14Boxed 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