Application 077456

Type: ANDA
Sponsor: KADMON PHARMS LLC

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077456-001	RIBAVIRIN	RIBAVIRIN	200MG	TABLET / ORAL	2005-12-05
A077456-002	RIBAVIRIN	RIBAVIRIN	400MG	TABLET / ORAL	2005-12-05
A077456-003	RIBAVIRIN	RIBAVIRIN	600MG	TABLET / ORAL	2005-12-05

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 2 of 4 · 132 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077456-002	RIBAVIRIN	400MG	TABLET / ORAL			2005-12-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077456-003	RIBAVIRIN	600MG	TABLET / ORAL			2005-12-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077456-001	RIBAVIRIN	200MG	TABLET / ORAL			2005-12-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077456-002	RIBAVIRIN	400MG	TABLET / ORAL			2005-12-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077456-003	RIBAVIRIN	600MG	TABLET / ORAL			2005-12-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077456-001	RIBAVIRIN	200MG	TABLET / ORAL			2005-12-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077456-002	RIBAVIRIN	400MG	TABLET / ORAL			2005-12-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077456-003	RIBAVIRIN	600MG	TABLET / ORAL			2005-12-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077456-001	RIBAVIRIN	200MG	TABLET / ORAL			2005-12-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077456-002	RIBAVIRIN	400MG	TABLET / ORAL			2005-12-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077456-003	RIBAVIRIN	600MG	TABLET / ORAL			2005-12-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077456-001	RIBAVIRIN	200MG	TABLET / ORAL			2005-12-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077456-002	RIBAVIRIN	400MG	TABLET / ORAL			2005-12-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077456-003	RIBAVIRIN	600MG	TABLET / ORAL			2005-12-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077456-001	RIBAVIRIN	200MG	TABLET / ORAL			2005-12-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077456-002	RIBAVIRIN	400MG	TABLET / ORAL			2005-12-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077456-003	RIBAVIRIN	600MG	TABLET / ORAL			2005-12-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077456-001	RIBAVIRIN	200MG	TABLET / ORAL			2005-12-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077456-002	RIBAVIRIN	400MG	TABLET / ORAL			2005-12-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077456-003	RIBAVIRIN	600MG	TABLET / ORAL			2005-12-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077456-001	RIBAVIRIN	200MG	TABLET / ORAL	AB		2005-12-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077456-002	RIBAVIRIN	400MG	TABLET / ORAL	AB		2005-12-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077456-003	RIBAVIRIN	600MG	TABLET / ORAL	AB	RS	2005-12-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077456-001	RIBAVIRIN	200MG	TABLET / ORAL			2005-12-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077456-002	RIBAVIRIN	400MG	TABLET / ORAL			2005-12-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077456-003	RIBAVIRIN	600MG	TABLET / ORAL			2005-12-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077456-001	RIBAVIRIN	200MG	TABLET / ORAL			2005-12-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077456-002	RIBAVIRIN	400MG	TABLET / ORAL			2005-12-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077456-003	RIBAVIRIN	600MG	TABLET / ORAL			2005-12-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077456-001	RIBAVIRIN	200MG	TABLET / ORAL			2005-12-05	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077456-002	RIBAVIRIN	400MG	TABLET / ORAL			2005-12-05	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077456-003	RIBAVIRIN	600MG	TABLET / ORAL			2005-12-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077456-001	RIBAVIRIN	200MG	TABLET / ORAL			2005-12-05	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077456-002	RIBAVIRIN	400MG	TABLET / ORAL			2005-12-05	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077456-003	RIBAVIRIN	600MG	TABLET / ORAL			2005-12-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077456-001	RIBAVIRIN	200MG	TABLET / ORAL			2005-12-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077456-002	RIBAVIRIN	400MG	TABLET / ORAL			2005-12-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077456-003	RIBAVIRIN	600MG	TABLET / ORAL			2005-12-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077456-001	RIBAVIRIN	200MG	TABLET / ORAL			2005-12-05	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077456-002	RIBAVIRIN	400MG	TABLET / ORAL			2005-12-05	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077456-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077456-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077456-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077456-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077456-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077456-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077456-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077456-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077456-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077456-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077456-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077456-003	AB	1	`ea99ee380514…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	Oceanside Pharmaceuticals	d74aa4f3-0b7d-480d-b5bf-41ddf808b260	2019-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ribavirin generic name: RIBAVIRIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-3197	Moderiba	Ribavirin	AbbVie Inc.	ANDA	Current
0074-3282	Moderiba	Ribavirin	AbbVie Inc.	ANDA	Current
54738-950	ribavirin	ribavirin	Richmond Pharmaceuticals, Inc.	ANDA	Current
54738-951	ribavirin	ribavirin	Richmond Pharmaceuticals, Inc.	ANDA	Current
54738-952	ribavirin	ribavirin	Richmond Pharmaceuticals, Inc.	ANDA	Current
66435-102	RIBASPHERE	ribavirin	Kadmon Pharmaceuticals, LLC	ANDA	Current
66435-103	RIBASPHERE	ribavirin	Kadmon Pharmaceuticals, LLC	ANDA	Current
66435-104	RIBASPHERE	ribavirin	Kadmon Pharmaceuticals, LLC	ANDA	Current
66435-105	RIBASPHERE RibaPak	ribavirin	Kadmon Pharmaceuticals, LLC	ANDA	Current
66435-106	RIBASPHERE RibaPak	ribavirin	Kadmon Pharmaceuticals, LLC	ANDA	Current
66435-107	RIBASPHERE RibaPak	ribavirin	Kadmon Pharmaceuticals, LLC	ANDA	Current
66435-108	RIBASPHERE RibaPak	ribavirin	Kadmon Pharmaceuticals, LLC	ANDA	Current