Application 018859

Type: NDA
Sponsor: VALEANT PHARM INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIRAZOLE	RIBAVIRIN	FOR SOLUTION;INHALATION	6GM/VIAL	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
N018859-001	VIRAZOLE	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION		RLD	1985-12-31

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	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION		RLD	1985-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION		RLD	1985-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N018859-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018859-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018859-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018859-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018859-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018859-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018859-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018859-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018859-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018859-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018859-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018859-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018859-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018859-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018859-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018859-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018859-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018859-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018859-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018859-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018859-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018859-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018859-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018859-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018859-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018859-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018859-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018859-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018859-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018859-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018859-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018859-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018859-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018859-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018859-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018859-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018859-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018859-001	AN	1	`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 · 2 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	Exact identifier application applno (NDA): 018859 application number: NDA018859
Ribavirin	RIBAVIRIN	Oceanside Pharmaceuticals	d74aa4f3-0b7d-480d-b5bf-41ddf808b260	2019-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018859 application number: NDA018859 ndc (product): 68682-019

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-0007	Virazole	Ribavirin	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0007	Virazole	Ribavirin	Bausch Health US, LLC	NDA	Current
0187-0007	Virazole	Ribavirin	Bausch Health US, LLC	NDA	Current
42494-423	Ribavirin	Ribavirin	Cameron Pharmaceuticals	NDA	Current
63629-2149	Ribavirin	Ribavirin	Bryant Ranch Prepack	NDA	Current
63629-2149	Ribavirin	Ribavirin	Bryant Ranch Prepack	NDA	Current
63629-2149	Ribavirin	Ribavirin	Bryant Ranch Prepack	NDA	Current
68682-019	Ribavirin	Ribavirin	Oceanside Pharmaceuticals	NDA	Current
68682-019	Ribavirin	Ribavirin	Oceanside Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57622	ORIG	2019-02-15