Application 204621

Type: ANDA
Sponsor: ALVOGEN

Application Products#

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

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

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
A204621-001	NEVIRAPINE	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL			2015-07-10
A204621-002	NEVIRAPINE	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL			2015-11-09

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 · 82 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	A204621-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		2015-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204621-002	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2015-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204621-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		2015-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204621-002	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2015-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204621-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		2015-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204621-002	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2015-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204621-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		2015-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204621-002	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2015-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204621-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		2015-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204621-002	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2015-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204621-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		2015-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204621-002	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2015-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204621-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		2015-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204621-002	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2015-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204621-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		2015-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204621-002	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2015-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204621-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		2015-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204621-002	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2015-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204621-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		2015-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204621-002	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2015-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204621-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		2015-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204621-002	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2015-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204621-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		2015-07-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204621-002	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2015-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204621-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		2015-07-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204621-002	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2015-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204621-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL		2015-07-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204621-002	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2015-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204621-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204621-002	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204621-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204621-002	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204621-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204621-002	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204621-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204621-002	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204621-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204621-002	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204621-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204621-002	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-09	`782e0a99824c…`

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	A204621-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204621-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204621-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204621-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204621-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204621-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204621-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204621-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204621-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204621-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204621-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204621-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204621-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204621-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204621-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204621-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204621-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204621-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204621-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204621-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204621-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204621-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204621-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204621-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204621-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204621-002	AB	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204621-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204621-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204621-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A204621-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204621-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204621-002	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 brand name: Nevirapine generic name: NEVIRAPINE
NEVIRAPINE	NEVIRAPINE	Micro Labs Limited	fbd628db-4076-4fe0-8323-9cc33ae92e42	2025-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: NEVIRAPINE generic name: NEVIRAPINE
Nevirapine	NEVIRAPINE	Mylan Pharmaceuticals Inc.	690da74b-2481-47fc-93ae-8340e0caf0a4	2024-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nevirapine generic name: NEVIRAPINE
Nevirapine	NEVIRAPINE	Aurobindo Pharma Limited	8dfe86aa-ea5d-48d2-94a8-1a5506055d70	2024-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nevirapine generic name: NEVIRAPINE
NEVIRAPINE	NEVIRAPINE	Macleods Pharmaceuticals Limited	2620b114-f53f-44f1-8708-697e86343090	2024-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: NEVIRAPINE generic name: NEVIRAPINE
Nevirapine	NEVIRAPINE	Aurobindo Pharma Limited	5f6c3eed-2a5d-46ed-9a7c-59715f338a15	2024-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nevirapine generic name: NEVIRAPINE
Nevirapine	NEVIRAPINE	Macleods Pharmaceuticals Limited	effb86cc-4b80-4fac-aaa3-9f373b3d0f7d	2023-08-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nevirapine generic name: NEVIRAPINE
Nevirapine	NEVIRAPINE	Camber Pharmaceuticals, Inc.	61409678-d2f6-42cd-b03d-b26b11b39641	2022-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nevirapine generic name: NEVIRAPINE
Nevirapine	NEVIRAPINE	Amneal Pharmaceuticals LLC	4f065674-4719-4c79-ba0d-549040d77f17	2012-08-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nevirapine generic name: NEVIRAPINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-317	Nevirapine Extended Release	nevirapine	Alvogen Inc.	ANDA	Current
47781-317	Nevirapine Extended Release	nevirapine	Alvogen Inc.	ANDA	Current
47781-317	Nevirapine Extended Release	nevirapine	Alvogen Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10363	ORIG	2015-11-17