Home Applications 021546 Application 021546
Type NDA
Sponsor SCHERING Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 REBETOL RIBAVIRIN SOLUTION;ORAL 40MG/ML Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N021546-001 REBETOL RIBAVIRIN 40MG/ML SOLUTION / ORAL RLD 2003-07-29
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 2 · 48 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021546-001 6790837 2023-04-05 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021546-001 6790837*PED 2023-10-05 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021546-001 6790837 2023-04-05 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021546-001 6790837*PED 2023-10-05 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021546-001 6790837 2023-04-05 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021546-001 6790837*PED 2023-10-05 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021546-001 6790837 2023-04-05 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021546-001 6790837*PED 2023-10-05 Pediatric extension 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021546-001 6790837 2023-04-05 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021546-001 6790837*PED 2023-10-05 Pediatric extension bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021546-001 6790837 2023-04-05 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021546-001 6790837*PED 2023-10-05 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021546-001 6790837 2023-04-05 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021546-001 6790837*PED 2023-10-05 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021546-001 6790837 2023-04-05 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021546-001 6790837*PED 2023-10-05 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021546-001 6790837 2023-04-05 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021546-001 6790837*PED 2023-10-05 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021546-001 6790837 2023-04-05 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021546-001 6790837*PED 2023-10-05 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021546-001 6790837 2023-04-05 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021546-001 6790837*PED 2023-10-05 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021546-001 6790837 2023-04-05 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021546-001 6790837*PED 2023-10-05 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021546-001 6790837 2023-04-05 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021546-001 6790837*PED 2023-10-05 Pediatric extension ea99ee380514…2023-12-20 04:57 UTC 2023-12 N021546-001 6790837 2023-04-05 Drug product ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N021546-001 6790837*PED 2023-10-05 Pediatric extension ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021546-001 6790837 2023-04-05 Drug product a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021546-001 6790837*PED 2023-10-05 Pediatric extension a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021546-001 6790837 2023-04-05 Drug product 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021546-001 6790837*PED 2023-10-05 Pediatric extension 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021546-001 6790837 2023-04-05 Drug product a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021546-001 6790837*PED 2023-10-05 Pediatric extension a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021546-001 6790837 2023-04-05 Drug product 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021546-001 6790837*PED 2023-10-05 Pediatric extension 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021546-001 6790837 2023-04-05 Drug product 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N021546-001 6790837*PED 2023-10-05 Pediatric extension 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021546-001 6790837 2023-04-05 Drug product 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N021546-001 6790837*PED 2023-10-05 Pediatric extension 3bdfa0b2c4d7…
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ribavirin RIBAVIRIN Bryant Ranch Prepack 3631ee95-692a-4426-8edf-62c27f7c32cb 2024-02-09 Boxed warning, Warnings, Adverse reactions Name fallback generic name: RIBAVIRIN Ribavirin RIBAVIRIN Aurobindo Pharma Limited 35f99f76-f2ef-4a81-91ff-285419664be3 2024-02-06 Boxed warning, Warnings, Adverse reactions Name fallback generic name: RIBAVIRIN Ribavirin RIBAVIRIN Aurobindo Pharma Limited eee304d0-c2ea-44f4-97d9-92a414d31b6c 2024-02-06 Boxed warning, Warnings, Adverse reactions Name fallback generic name: RIBAVIRIN Ribavirin RIBAVIRIN Oceanside Pharmaceuticals d74aa4f3-0b7d-480d-b5bf-41ddf808b260 2019-05-01 Boxed warning, Warnings, Adverse reactions Name fallback generic name: RIBAVIRIN
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0085-1318 REBETOL ribavirin Merck Sharp & Dohme Corp. NDA Current 0085-1318 REBETOL ribavirin Merck Sharp & Dohme Corp. NDA Current 0085-1318 REBETOL ribavirin Merck Sharp & Dohme Corp. NDA Current 0085-1318 REBETOL ribavirin Merck Sharp & Dohme Corp. NDA Current 0085-1318 REBETOL ribavirin Merck Sharp & Dohme Corp. NDA Current