Application 020636

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIRAMUNE	NEVIRAPINE	TABLET;ORAL	200MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020636-001	VIRAMUNE	NEVIRAPINE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-21

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 1 of 2 · 42 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
2026-08-18 06:07:40	2026-07	N020636-001	VIRAMUNE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020636-001	VIRAMUNE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020636-001	VIRAMUNE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020636-001	VIRAMUNE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020636-001	VIRAMUNE	200MG	TABLET / ORAL		RLD	1996-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020636-001	VIRAMUNE	200MG	TABLET / ORAL		RLD	1996-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020636-001	VIRAMUNE	200MG	TABLET / ORAL		RLD	1996-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020636-001	VIRAMUNE	200MG	TABLET / ORAL		RLD	1996-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020636-001	VIRAMUNE	200MG	TABLET / ORAL		RLD	1996-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020636-001	VIRAMUNE	200MG	TABLET / ORAL		RLD	1996-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020636-001	VIRAMUNE	200MG	TABLET / ORAL		RLD	1996-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020636-001	VIRAMUNE	200MG	TABLET / ORAL		RLD	1996-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020636-001	VIRAMUNE	200MG	TABLET / ORAL		RLD	1996-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020636-001	VIRAMUNE	200MG	TABLET / ORAL		RLD	1996-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020636-001	VIRAMUNE	200MG	TABLET / ORAL		RLD	1996-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020636-001	VIRAMUNE	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020636-001	VIRAMUNE	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020636-001	VIRAMUNE	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020636-001	VIRAMUNE	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020636-001	VIRAMUNE	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020636-001	VIRAMUNE	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020636-001	VIRAMUNE	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020636-001	VIRAMUNE	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020636-001	VIRAMUNE	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020636-001	VIRAMUNE	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020636-001	VIRAMUNE	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020636-001	VIRAMUNE	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020636-001	VIRAMUNE	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020636-001	VIRAMUNE	200MG	TABLET / ORAL		RLD	1996-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020636-001	VIRAMUNE	200MG	TABLET / ORAL		RLD	1996-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020636-001	VIRAMUNE	200MG	TABLET / ORAL		RLD	1996-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020636-001	VIRAMUNE	200MG	TABLET / ORAL		RLD	1996-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020636-001	VIRAMUNE	200MG	TABLET / ORAL		RLD	1996-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020636-001	VIRAMUNE	200MG	TABLET / ORAL		RLD	1996-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020636-001	VIRAMUNE	200MG	TABLET / ORAL		RLD	1996-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020636-001	VIRAMUNE	200MG	TABLET / ORAL		RLD	1996-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020636-001	VIRAMUNE	200MG	TABLET / ORAL		RLD	1996-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020636-001	VIRAMUNE	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020636-001	VIRAMUNE	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020636-001	VIRAMUNE	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020636-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020636-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020636-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020636-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020636-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020636-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020636-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020636-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020636-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020636-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020636-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020636-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020636-001	AB	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020636-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020636-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020636-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020636-001	AB	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nevirapine	NEVIRAPINE	Mylan Pharmaceuticals Inc.	c6e93829-7024-48f6-8023-da6ff27dfc0a	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NEVIRAPINE
NEVIRAPINE	NEVIRAPINE	Micro Labs Limited	fbd628db-4076-4fe0-8323-9cc33ae92e42	2025-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NEVIRAPINE
Nevirapine	NEVIRAPINE	Mylan Pharmaceuticals Inc.	690da74b-2481-47fc-93ae-8340e0caf0a4	2024-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NEVIRAPINE
Nevirapine	NEVIRAPINE	Aurobindo Pharma Limited	8dfe86aa-ea5d-48d2-94a8-1a5506055d70	2024-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NEVIRAPINE
NEVIRAPINE	NEVIRAPINE	Macleods Pharmaceuticals Limited	2620b114-f53f-44f1-8708-697e86343090	2024-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NEVIRAPINE
Nevirapine	NEVIRAPINE	Aurobindo Pharma Limited	5f6c3eed-2a5d-46ed-9a7c-59715f338a15	2024-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NEVIRAPINE
Nevirapine	NEVIRAPINE	Macleods Pharmaceuticals Limited	effb86cc-4b80-4fac-aaa3-9f373b3d0f7d	2023-08-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NEVIRAPINE
Nevirapine	NEVIRAPINE	Camber Pharmaceuticals, Inc.	61409678-d2f6-42cd-b03d-b26b11b39641	2022-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NEVIRAPINE
Nevirapine	NEVIRAPINE	Amneal Pharmaceuticals LLC	4f065674-4719-4c79-ba0d-549040d77f17	2012-08-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NEVIRAPINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0046	Viramune	nevirapine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0046	Viramune	nevirapine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0046	Viramune	nevirapine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
53808-0808	Viramune	nevirapine	State of Florida DOH Central Pharmacy	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71313	SUPPL	2022-06-15
71312	SUPPL	2022-06-15
71284	SUPPL	2022-06-13
57682	ORIG	2019-02-15
55742	SUPPL	2018-10-01
55615	SUPPL	2018-09-25
55613	SUPPL	2018-09-25
47768	SUPPL	2017-03-29
47735	SUPPL	2017-03-28
25413	SUPPL	2014-01-28
12906	SUPPL	2014-01-28
35050	SUPPL	2012-11-15
25412	SUPPL	2012-11-13
2966	SUPPL	2011-11-14
35049	SUPPL	2011-11-10
25411	SUPPL	2011-05-10
2965	SUPPL	2011-03-31
12905	SUPPL	2011-03-28
25410	SUPPL	2011-01-14
35048	SUPPL	2011-01-10
2964	SUPPL	2010-07-23
35047	SUPPL	2010-07-22
25409	SUPPL	2010-01-26
12904	SUPPL	2010-01-20
2963	SUPPL	2008-06-30
35045	SUPPL	2008-06-26
35046	SUPPL	2007-08-17
25408	SUPPL	2007-08-17
41513	SUPPL	2007-08-06
20797	SUPPL	2007-08-06
20795	SUPPL	2007-08-06
20793	SUPPL	2007-08-06
20792	SUPPL	2007-08-06
25407	SUPPL	2007-04-20
12903	SUPPL	2007-04-20
20796	SUPPL	2005-04-27
35044	SUPPL	2005-03-02
2962	SUPPL	2005-03-02
35040	SUPPL	2004-06-30
25404	SUPPL	2004-06-30
25403	SUPPL	2004-06-30
12902	SUPPL	2004-05-27
2961	SUPPL	2004-05-26
20794	SUPPL	2004-02-04
35043	SUPPL	2003-12-29
2960	SUPPL	2003-12-23
35042	SUPPL	2003-08-06
25406	SUPPL	2003-08-06
35041	SUPPL	2003-04-04
25405	SUPPL	2002-03-27