Application 076192

Type: ANDA
Sponsor: CHARTWELL RX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RIBAVIRIN	RIBAVIRIN	CAPSULE;ORAL	200MG	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
A076192-001	RIBAVIRIN	RIBAVIRIN	200MG	CAPSULE / ORAL			2004-04-06

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076192-001	RIBAVIRIN	200MG	CAPSULE / ORAL	2004-04-06	`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 · 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 brand name: Ribavirin generic name: RIBAVIRIN
Ribavirin	RIBAVIRIN	Aurobindo Pharma Limited	35f99f76-f2ef-4a81-91ff-285419664be3	2024-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ribavirin generic name: RIBAVIRIN
Ribavirin	RIBAVIRIN	Aurobindo Pharma Limited	eee304d0-c2ea-44f4-97d9-92a414d31b6c	2024-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ribavirin generic name: RIBAVIRIN
RIBAVIRIN	RIBAVIRIN	Zydus Pharmaceuticals USA Inc.	2c3a64d5-fde2-437b-bafc-e76dd187d85a	2022-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RIBAVIRIN generic name: RIBAVIRIN
RIBAVIRIN	RIBAVIRIN	Navinta LLC	39723ea2-780c-4266-954a-869723b144c4	2022-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RIBAVIRIN generic name: RIBAVIRIN
Ribavirin	RIBAVIRIN	Oceanside Pharmaceuticals	d74aa4f3-0b7d-480d-b5bf-41ddf808b260	2019-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ribavirin generic name: RIBAVIRIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-2043	Ribavirin	Ribavirin	Sandoz Inc	ANDA	Current
53808-0781	Ribavirin	RIBAVIRIN	State of Florida DOH Central Pharmacy	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44434	ORIG	2004-04-09
18444	ORIG	2004-04-09
31097	ORIG	2004-04-07