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 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
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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021546-001	REBETOL	40MG/ML	SOLUTION / ORAL	RLD	2003-07-29	`cb3db0bc1861…`

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	Coverage / status	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 · 6 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	Zydus Pharmaceuticals USA Inc.	2c3a64d5-fde2-437b-bafc-e76dd187d85a	2022-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RIBAVIRIN
RIBAVIRIN	RIBAVIRIN	Navinta LLC	39723ea2-780c-4266-954a-869723b144c4	2022-12-02	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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70571	SUPPL	2022-03-21
70570	SUPPL	2022-03-21
70542	SUPPL	2022-03-17
61727	SUPPL	2020-01-29
61726	SUPPL	2020-01-29
61717	SUPPL	2020-01-29
58556	SUPPL	2019-05-03
58546	SUPPL	2019-05-03
15742	SUPPL	2015-05-27
28084	SUPPL	2015-05-22
37200	SUPPL	2013-11-22
28083	SUPPL	2013-11-18
15741	SUPPL	2013-06-04
5696	SUPPL	2013-06-04
37199	SUPPL	2013-02-08
28082	SUPPL	2013-02-08
5695	SUPPL	2011-05-10
5694	SUPPL	2010-11-03
37198	SUPPL	2010-10-29
28081	SUPPL	2010-01-20
37197	SUPPL	2009-11-16
42207	ORIG	2005-04-08
15740	ORIG	2004-06-14
5693	ORIG	2003-08-06