Application 022417

Type: NDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NORVIR	RITONAVIR	TABLET;ORAL	100MG	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
N022417-001	NORVIR	RITONAVIR	100MG	TABLET / ORAL	AB	RLD	2010-02-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N022417-001	AB

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	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD	2010-02-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD	2010-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022417-001	NORVIR	100MG	TABLET / ORAL	AB	RLD, RS	2010-02-10	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022417-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022417-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022417-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022417-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022417-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022417-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022417-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022417-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022417-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022417-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022417-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022417-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022417-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022417-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022417-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022417-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022417-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022417-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022417-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022417-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022417-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022417-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022417-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022417-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022417-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022417-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022417-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022417-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022417-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022417-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022417-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022417-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022417-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022417-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022417-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022417-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022417-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022417-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022417-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022417-001	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022417-001	7148359	2019-07-19		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022417-001	7148359*PED	2020-01-19		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022417-001	7364752	2020-11-10	U-688	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022417-001	7364752*PED	2021-05-10		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022417-001	8268349	2024-08-25		Drug product	2012-09-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022417-001	8399015	2024-08-25		Drug product	2013-04-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022417-001	8691878	2024-08-25	U-688		2014-06-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022417-001	8268349*PED	2025-02-25		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022417-001	8399015*PED	2025-02-25		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022417-001	8691878*PED	2025-02-25		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022417-001	8470347	2026-09-17		Drug product	2013-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022417-001	8470347*PED	2027-03-17		Pediatric extension		`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022417-001	7148359	2019-07-19		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022417-001	7148359*PED	2020-01-19		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022417-001	7364752	2020-11-10	U-688	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022417-001	7364752*PED	2021-05-10		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022417-001	8268349	2024-08-25		Drug product	2012-09-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022417-001	8399015	2024-08-25		Drug product	2013-04-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022417-001	8691878	2024-08-25	U-688		2014-06-10	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022417-001	8268349*PED	2025-02-25		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022417-001	8399015*PED	2025-02-25		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022417-001	8691878*PED	2025-02-25		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022417-001	8470347	2026-09-17		Drug product	2013-07-12	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022417-001	8470347*PED	2027-03-17		Pediatric extension		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022417-001	7148359	2019-07-19		Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022417-001	7148359*PED	2020-01-19		Pediatric extension		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022417-001	7364752	2020-11-10	U-688	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022417-001	7364752*PED	2021-05-10		Pediatric extension		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022417-001	8268349	2024-08-25		Drug product	2012-09-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022417-001	8399015	2024-08-25		Drug product	2013-04-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022417-001	8691878	2024-08-25	U-688		2014-06-10	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022417-001	8268349*PED	2025-02-25		Pediatric extension		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022417-001	8399015*PED	2025-02-25		Pediatric extension		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022417-001	8691878*PED	2025-02-25		Pediatric extension		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022417-001	8470347	2026-09-17		Drug product	2013-07-12	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022417-001	8470347*PED	2027-03-17		Pediatric extension		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022417-001	7148359	2019-07-19		Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022417-001	7148359*PED	2020-01-19		Pediatric extension		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022417-001	7364752	2020-11-10	U-688	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022417-001	7364752*PED	2021-05-10		Pediatric extension		`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Norvir	RITONAVIR	AbbVie Inc.	2849298e-de6e-47bb-8194-56e075b33fc3	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022417 application number: NDA022417 ndc (product): 0074-3333 ndc (product): 0074-2340

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-2340	Norvir	Ritonavir	AbbVie Inc.	NDA	Current
0074-2340	Norvir	Ritonavir	AbbVie Inc.	NDA	Current
0074-3333	Norvir	Ritonavir	AbbVie Inc.	NDA	Current
0074-3333	Norvir	Ritonavir	AbbVie Inc.	NDA	Current
0074-3333	Norvir	Ritonavir	AbbVie Inc.	NDA	Current
0074-3333	Norvir	Ritonavir	AbbVie Inc.	NDA	Current
0074-3333	Norvir	Ritonavir	AbbVie Inc.	NDA	Current
0074-3333	Norvir	Ritonavir	AbbVie Inc.	NDA	Current
0074-3333	Norvir	Ritonavir	AbbVie Inc.	NDA	Current
0074-3333	Norvir	Ritonavir	AbbVie Inc.	NDA	Current
0074-3333	Norvir	Ritonavir	AbbVie Inc.	NDA	Current
50090-1162	Norvir	Ritonavir	A-S Medication Solutions	NDA	Current
53808-1119	Norvir	Ritonavir	DOH CENTRAL PHARMACY	NDA	Current
67296-1234	Norvir	Norvir	RedPharm Drug, Inc.	NDA	Current
67296-1234	Norvir	Norvir	RedPharm Drug, Inc.	NDA	Current
68382-696	Ritonavir	Ritonavir	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-696	Ritonavir	Ritonavir	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72958	SUPPL	2022-12-20
72916	SUPPL	2022-12-16
65023	SUPPL	2020-10-23
64974	SUPPL	2020-10-22
61485	SUPPL	2019-12-31
61380	SUPPL	2019-12-23
59815	SUPPL	2019-08-22
59806	SUPPL	2019-08-22
56682	SUPPL	2018-12-07
56540	SUPPL	2018-11-23
49925	SUPPL	2017-10-03
49918	SUPPL	2017-10-03
48885	SUPPL	2017-06-30
48877	SUPPL	2017-06-30
48679	SUPPL	2017-06-08
48678	SUPPL	2017-06-08
46531	SUPPL	2016-12-23
46512	SUPPL	2016-12-22
45993	SUPPL	2016-12-01
45949	SUPPL	2016-11-23
45285	SUPPL	2016-09-19
45310	SUPPL	2016-09-15
29704	SUPPL	2015-11-17
17564	SUPPL	2015-11-12
17563	SUPPL	2015-04-07
7357	SUPPL	2015-04-03
38680	SUPPL	2015-03-19
7356	SUPPL	2015-03-17
17562	SUPPL	2013-11-08
7355	SUPPL	2013-11-08
38679	SUPPL	2012-11-28
7354	SUPPL	2012-11-23
7353	SUPPL	2012-02-27
38678	SUPPL	2012-02-22
17561	SUPPL	2011-12-14
7352	SUPPL	2011-12-08
42517	ORIG	2010-06-06
24302	ORIG	2010-06-06
17560	SUPPL	2010-05-07
29703	SUPPL	2010-05-03
7351	ORIG	2010-02-17
38677	ORIG	2010-02-16