Application 021511

Type: NDA
Sponsor: ROCHE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COPEGUS	RIBAVIRIN	TABLET;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
002	COPEGUS	RIBAVIRIN	TABLET;ORAL	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021511-001	COPEGUS	RIBAVIRIN	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-12-03
N021511-002	COPEGUS	RIBAVIRIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-06-21

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021511-001	COPEGUS	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		2002-12-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021511-002	COPEGUS	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		2005-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021511-001	COPEGUS	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-12-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021511-002	COPEGUS	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021511-001	COPEGUS	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2002-12-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021511-002	COPEGUS	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2005-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021511-001	COPEGUS	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2002-12-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021511-002	COPEGUS	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2005-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021511-001	COPEGUS	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2002-12-03	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021511-002	COPEGUS	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2005-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021511-001	COPEGUS	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2002-12-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021511-002	COPEGUS	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2005-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021511-001	COPEGUS	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		2002-12-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021511-002	COPEGUS	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		2005-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021511-001	COPEGUS	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		2002-12-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021511-002	COPEGUS	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		2005-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021511-001	COPEGUS	200MG	TABLET / ORAL		2002-12-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021511-002	COPEGUS	400MG	TABLET / ORAL		2005-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021511-001	COPEGUS	200MG	TABLET / ORAL		2002-12-03	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021511-002	COPEGUS	400MG	TABLET / ORAL		2005-06-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021511-001	COPEGUS	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-12-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021511-002	COPEGUS	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021511-001	COPEGUS	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-12-03	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021511-002	COPEGUS	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021511-001	COPEGUS	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-12-03	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021511-002	COPEGUS	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021511-001	COPEGUS	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-12-03	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021511-002	COPEGUS	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021511-001	COPEGUS	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-12-03	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021511-002	COPEGUS	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021511-001	COPEGUS	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-12-03	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021511-002	COPEGUS	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021511-001	COPEGUS	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-12-03	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021511-002	COPEGUS	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021511-001	COPEGUS	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-12-03	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021511-002	COPEGUS	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021511-001	COPEGUS	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-12-03	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021511-002	COPEGUS	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021511-001	COPEGUS	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-12-03	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021511-002	COPEGUS	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-06-21	`3a93d1ddd44b…`

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 generic name: RIBAVIRIN
Ribavirin	RIBAVIRIN	Aurobindo Pharma Limited	eee304d0-c2ea-44f4-97d9-92a414d31b6c	2024-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RIBAVIRIN
Ribavirin	RIBAVIRIN	Oceanside Pharmaceuticals	d74aa4f3-0b7d-480d-b5bf-41ddf808b260	2019-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RIBAVIRIN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
46117	SUPPL	2016-12-09
37108	SUPPL	2015-08-12
5586	SUPPL	2015-08-12
37107	SUPPL	2013-02-08
27980	SUPPL	2013-02-08
27978	SUPPL	2011-08-26
37106	SUPPL	2011-08-24
27977	SUPPL	2011-08-11
15638	SUPPL	2011-08-11
27979	SUPPL	2011-05-11
37105	SUPPL	2010-12-22
27976	SUPPL	2010-12-22
27975	SUPPL	2010-10-13
15637	SUPPL	2010-10-12
37104	SUPPL	2010-06-24
5585	SUPPL	2010-06-15
27974	SUPPL	2010-03-08
37103	SUPPL	2010-03-05
27973	SUPPL	2009-05-07
5584	SUPPL	2009-05-07
27972	SUPPL	2008-04-22
5583	SUPPL	2007-07-05
37102	SUPPL	2007-06-27
37101	SUPPL	2005-11-30
27971	SUPPL	2005-11-30
24002	SUPPL	2005-11-01
24003	SUPPL	2005-09-22
15636	SUPPL	2005-08-24
5581	SUPPL	2005-08-24
37100	SUPPL	2005-08-19
27970	SUPPL	2005-08-19
5582	SUPPL	2005-06-23
27969	SUPPL	2005-03-03
15635	SUPPL	2005-03-03
21706	ORIG	2004-08-10
15634	SUPPL	2004-05-07
5580	SUPPL	2004-05-07
27968	ORIG	2002-12-03
15633	ORIG	2002-12-03
53396	ORIG	1900-01-01
53395	ORIG	1900-01-01
53394	ORIG	1900-01-01