Application 077094

Type: ANDA
Sponsor: ZYDUS PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RIBAVIRIN	RIBAVIRIN	TABLET;ORAL	200MG	No	No
002	RIBAVIRIN	RIBAVIRIN	TABLET;ORAL	400MG	No	No
003	RIBAVIRIN	RIBAVIRIN	TABLET;ORAL	600MG	No	No
004	RIBAVIRIN	RIBAVIRIN	TABLET;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077094-001	RIBAVIRIN	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05
A077094-002	RIBAVIRIN	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16
A077094-003	RIBAVIRIN	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16
A077094-004	RIBAVIRIN	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A077094-001	AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077094-001	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077094-002	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077094-003	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077094-004	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077094-001	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077094-002	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077094-003	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077094-004	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077094-001	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077094-002	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077094-003	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077094-004	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077094-001	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077094-002	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077094-003	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077094-004	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077094-001	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077094-002	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077094-003	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077094-004	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077094-001	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077094-002	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077094-003	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077094-004	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077094-001	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077094-002	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077094-003	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077094-004	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077094-001	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077094-002	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077094-003	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077094-004	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077094-001	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077094-002	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077094-003	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077094-004	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077094-001	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077094-002	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077094-003	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077094-004	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 53 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077094-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077094-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077094-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077094-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077094-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077094-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077094-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077094-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077094-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077094-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077094-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077094-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077094-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077094-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077094-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077094-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077094-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077094-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077094-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077094-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077094-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077094-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077094-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077094-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077094-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077094-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077094-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077094-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077094-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077094-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077094-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077094-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077094-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077094-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077094-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077094-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077094-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077094-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077094-004	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077094-001	AB	1	`6a51e52b5d6a…`

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 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65841-046	Ribavirin	Ribavirin	Cadila Healthcare Limited	ANDA	Current
65841-046	Ribavirin	Ribavirin	Cadila Healthcare Limited	ANDA	Current
65841-046	Ribavirin	Ribavirin	Cadila Healthcare Limited	ANDA	Current
65841-046	Ribavirin	Ribavirin	Cadila Healthcare Limited	ANDA	Current
65841-046	Ribavirin	Ribavirin	Zydus Lifesciences Limited	ANDA	Current
65841-129	Ribavirin	Ribavirin	Cadila Healthcare Limited	ANDA	Current
65841-129	Ribavirin	Ribavirin	Cadila Healthcare Limited	ANDA	Current
65841-129	Ribavirin	Ribavirin	Cadila Healthcare Limited	ANDA	Current
65841-129	Ribavirin	Ribavirin	Cadila Healthcare Limited	ANDA	Current
65841-129	Ribavirin	Ribavirin	Zydus Lifesciences Limited	ANDA	Current
65841-603	Ribavirin	Ribavirin	Cadila Healthcare Limited	ANDA	Current
65841-603	Ribavirin	Ribavirin	Cadila Healthcare Limited	ANDA	Current
65841-603	Ribavirin	Ribavirin	Cadila Healthcare Limited	ANDA	Current
65841-603	Ribavirin	Ribavirin	Cadila Healthcare Limited	ANDA	Current
65841-603	Ribavirin	Ribavirin	Zydus Lifesciences Limited	ANDA	Current
65841-632	Ribavirin	Ribavirin	Cadila Healthcare Limited	ANDA	Current
65841-632	Ribavirin	Ribavirin	Cadila Healthcare Limited	ANDA	Current
65841-632	Ribavirin	Ribavirin	Cadila Healthcare Limited	ANDA	Current
65841-632	Ribavirin	Ribavirin	Cadila Healthcare Limited	ANDA	Current
65841-632	Ribavirin	Ribavirin	Zydus Lifesciences Limited	ANDA	Current
68382-046	Ribavirin	Ribavirin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-046	Ribavirin	Ribavirin	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-046	Ribavirin	Ribavirin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-127	Ribavirin	Ribavirin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-127	Ribavirin	Ribavirin	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-127	Ribavirin	Ribavirin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-128	Ribavirin	Ribavirin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-128	Ribavirin	Ribavirin	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-128	Ribavirin	Ribavirin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-129	Ribavirin	Ribavirin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-129	Ribavirin	Ribavirin	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-129	Ribavirin	Ribavirin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31196	ORIG	2005-10-20