Application 207366

Type: ANDA
Sponsor: NAVINTA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RIBAVIRIN	RIBAVIRIN	FOR SOLUTION;INHALATION	6GM/VIAL	No	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
A207366-001	RIBAVIRIN	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION			2016-10-06

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	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION		RS	2016-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION		RS	2016-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207366-001	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION	AN		2016-10-06	`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	A207366-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207366-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207366-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207366-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207366-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207366-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207366-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207366-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207366-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207366-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207366-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207366-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207366-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207366-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207366-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207366-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207366-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207366-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207366-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207366-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207366-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207366-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207366-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207366-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207366-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207366-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207366-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207366-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207366-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207366-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207366-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207366-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207366-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207366-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207366-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207366-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207366-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207366-001	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	Zydus Pharmaceuticals USA Inc.	2c3a64d5-fde2-437b-bafc-e76dd187d85a	2022-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207366 application number: ANDA207366 ndc (product): 68382-395
RIBAVIRIN	RIBAVIRIN	Navinta LLC	39723ea2-780c-4266-954a-869723b144c4	2022-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207366 application number: ANDA207366 ndc (product): 68475-003

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
68382-395	RIBAVIRIN	ribavirin	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-395	RIBAVIRIN	ribavirin	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-395	RIBAVIRIN	ribavirin	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68475-003	RIBAVIRIN	ribavirin	Navinta LLC	ANDA	Current
68475-003	RIBAVIRIN	ribavirin	Navinta LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45576	ORIG	2016-10-14