Application 201152

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIRAMUNE XR	NEVIRAPINE	TABLET, EXTENDED RELEASE;ORAL	400MG	Yes	Yes
002	VIRAMUNE XR	NEVIRAPINE	TABLET, EXTENDED RELEASE;ORAL	100MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N201152-001	VIRAMUNE XR	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2011-03-25
N201152-002	VIRAMUNE XR	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-11-08

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N201152-001	8460704	2029-03-12	U-1409		2013-06-21

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 3 · 86 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
2026-09-14 22:38:34	2026-08	N201152-001	VIRAMUNE XR	400MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2011-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201152-002	VIRAMUNE XR	100MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-11-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201152-001	VIRAMUNE XR	400MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2011-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201152-002	VIRAMUNE XR	100MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-11-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201152-001	VIRAMUNE XR	400MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2011-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201152-002	VIRAMUNE XR	100MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201152-001	VIRAMUNE XR	400MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2011-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201152-002	VIRAMUNE XR	100MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201152-001	VIRAMUNE XR	400MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2011-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201152-002	VIRAMUNE XR	100MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201152-001	VIRAMUNE XR	400MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2011-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201152-002	VIRAMUNE XR	100MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201152-001	VIRAMUNE XR	400MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2011-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201152-002	VIRAMUNE XR	100MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201152-001	VIRAMUNE XR	400MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2011-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201152-002	VIRAMUNE XR	100MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201152-001	VIRAMUNE XR	400MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2011-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201152-002	VIRAMUNE XR	100MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201152-001	VIRAMUNE XR	400MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2011-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201152-002	VIRAMUNE XR	100MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201152-001	VIRAMUNE XR	400MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2011-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201152-002	VIRAMUNE XR	100MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201152-001	VIRAMUNE XR	400MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2011-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201152-002	VIRAMUNE XR	100MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201152-001	VIRAMUNE XR	400MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2011-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201152-002	VIRAMUNE XR	100MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201152-001	VIRAMUNE XR	400MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2011-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201152-002	VIRAMUNE XR	100MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201152-001	VIRAMUNE XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2011-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201152-002	VIRAMUNE XR	100MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201152-001	VIRAMUNE XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2011-03-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N201152-002	VIRAMUNE XR	100MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2012-11-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201152-001	VIRAMUNE XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2011-03-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201152-002	VIRAMUNE XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-11-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201152-001	VIRAMUNE XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2011-03-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201152-002	VIRAMUNE XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-11-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201152-001	VIRAMUNE XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2011-03-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201152-002	VIRAMUNE XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-11-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201152-001	VIRAMUNE XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2011-03-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201152-002	VIRAMUNE XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-11-08	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 49 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201152-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201152-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201152-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201152-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201152-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201152-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201152-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201152-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201152-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201152-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201152-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201152-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201152-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201152-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201152-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201152-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201152-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N201152-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201152-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N201152-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201152-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N201152-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201152-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N201152-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201152-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N201152-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201152-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N201152-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N201152-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N201152-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N201152-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201152-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201152-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201152-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201152-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201152-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201152-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201152-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N201152-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201152-001	AB	1	`3bdfa0b2c4d7…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N201152-001	8460704	2029-03-12	U-1409	2013-06-21	`f41ea6bd6efb…`

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0123	Viramune	nevirapine	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0123	Viramune	nevirapine	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0123	Viramune	nevirapine	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0123	Viramune	nevirapine	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0123	Viramune	nevirapine	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79164	SUPPL	2024-07-24
79163	SUPPL	2024-07-24
79150	SUPPL	2024-07-23
71319	SUPPL	2022-06-15
71318	SUPPL	2022-06-15
71276	SUPPL	2022-06-13
55744	SUPPL	2018-10-01
55611	SUPPL	2018-09-25
55610	SUPPL	2018-09-25
47764	SUPPL	2017-03-29
47739	SUPPL	2017-03-28
18993	SUPPL	2014-01-28
9863	SUPPL	2014-01-28
9861	SUPPL	2012-11-13
18991	SUPPL	2012-11-08
18992	SUPPL	2012-10-04
9862	SUPPL	2012-10-03
44830	ORIG	2012-06-29
22844	ORIG	2012-06-29
24098	ORIG	2011-11-17
32084	SUPPL	2011-11-14
40050	SUPPL	2011-11-10
9860	SUPPL	2011-05-10
18990	ORIG	2011-03-29
9859	ORIG	2011-03-29
63228	ORIG	1900-01-01
54064	ORIG	1900-01-01
51403	ORIG	1900-01-01
51402	ORIG	1900-01-01