Home Applications 021591 Application 021591
Type NDA
Sponsor RANBAXY Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RIOMET METFORMIN HYDROCHLORIDE SOLUTION;ORAL 500MG/5ML Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021591-001 RIOMET METFORMIN HYDROCHLORIDE 500MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2003-09-11
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021591-001 RIOMET 500MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2003-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021591-001 RIOMET 500MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2003-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021591-001 RIOMET 500MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2003-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL AB RLD, RS 2003-09-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL AB RLD, RS 2003-09-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL AB RLD, RS 2003-09-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD, RS 2003-09-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL AB RLD, RS 2003-09-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL AB RLD, RS 2003-09-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL AB RLD, RS 2003-09-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL AB RLD, RS 2003-09-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL AB RLD, RS 2003-09-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL AB RLD, RS 2003-09-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD, RS 2003-09-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD, RS 2003-09-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD, RS 2003-09-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL RLD 2003-09-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL AB RLD, RS 2003-09-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL AB RLD, RS 2003-09-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021591-001 RIOMET 500MG/5ML SOLUTION / ORAL AB RLD, RS 2003-09-11 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021591-001 6890957 2021-08-07 Drug product 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021591-001 6890957 2021-08-07 Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021591-001 6890957 2021-08-07 Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021591-001 6890957 2021-08-07 Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021591-001 6890957 2021-08-07 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021591-001 6890957 2021-08-07 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021591-001 6890957 2021-08-07 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021591-001 6890957 2021-08-07 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021591-001 6890957 2021-08-07 Drug product ea99ee380514…
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Riomet METFORMIN HYDROCHLORIDE Sun Pharmaceutical Industries, Inc. 05d4df4b-dfe8-4828-b423-a3d4f2c4114a 2018-12-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021591 application number: NDA021591 ndc (product): 10631-206 ndc (product): 10631-238
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10631-206 Riomet Metformin Hydrochloride Sun Pharmaceutical Industries, Inc. NDA Current 10631-238 Riomet Metformin Hydrochloride Sun Pharmaceutical Industries, Inc. NDA Current 71800-008 Metformin Hydrochloride Metformin Hydrochloride INNOVIDA PHARMACEUTIQUE CORPORATION NDA Current 71800-008 Metformin Hydrochloride Metformin Hydrochloride INNOVIDA PHARMACEUTIQUE CORPORATION NDA Current