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 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021546-001 REBETOL 40MG/ML SOLUTION / ORAL RLD 2003-07-29 84e616aacf4f…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…
Observed Orange Book patent history# Patent history page 2 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 2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021546-001 6790837 2023-04-05 Drug product 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021546-001 6790837*PED 2023-10-05 Pediatric extension 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021546-001 6790837 2023-04-05 Drug product f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021546-001 6790837*PED 2023-10-05 Pediatric extension f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021546-001 6790837 2023-04-05 Drug product e64feba35796…2022-09-29 23:25 UTC 2022-09 N021546-001 6790837*PED 2023-10-05 Pediatric extension e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021546-001 6790837 2023-04-05 Drug product cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021546-001 6790837*PED 2023-10-05 Pediatric extension cb3db0bc1861…
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 · 3 matching rows.
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 · 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