Application 209512

Type: NDA
Sponsor: ABBVIE INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NORVIR	RITONAVIR	POWDER;ORAL	100MG/PACKET	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
N209512-001	NORVIR	RITONAVIR	100MG/PACKET	POWDER / ORAL		RLD, RS	2017-06-07

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209512-001	NORVIR	100MG/PACKET	POWDER / ORAL	RLD, RS	2017-06-07	`e64feba35796…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N209512-001	ODE-184	2024-06-07	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N209512-001	ODE-184	2024-06-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209512-001	ODE-184	2024-06-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209512-001	ODE-184	2024-06-07	`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): 209512 application number: NDA209512 ndc (product): 0074-3399

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-3399	Norvir	Ritonavir	AbbVie Inc.	NDA	Current
0074-3399	Norvir	Ritonavir	AbbVie Inc.	NDA	Current
0074-3399	Norvir	Ritonavir	AbbVie Inc.	NDA	Current
0074-3399	Norvir	Ritonavir	AbbVie Inc.	NDA	Current
0074-3399	Norvir	Ritonavir	AbbVie Inc.	NDA	Current
0074-3399	Norvir	Ritonavir	AbbVie Inc.	NDA	Current
0074-3399	Norvir	Ritonavir	AbbVie Inc.	NDA	Current
0074-3399	Norvir	Ritonavir	AbbVie Inc.	NDA	Current
0074-3399	Norvir	Ritonavir	AbbVie Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72960	SUPPL	2022-12-20
72918	SUPPL	2022-12-16
65024	SUPPL	2020-10-23
64975	SUPPL	2020-10-22
61484	SUPPL	2019-12-31
61379	SUPPL	2019-12-23
59816	SUPPL	2019-08-22
59805	SUPPL	2019-08-22
56683	SUPPL	2018-12-07
56542	SUPPL	2018-11-23
52958	ORIG	2018-03-14
52853	ORIG	2018-03-08
49926	SUPPL	2017-10-03
49919	SUPPL	2017-10-03
48886	SUPPL	2017-06-30
48878	SUPPL	2017-06-30
48671	ORIG	2017-06-08