Application 021814

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	APTIVUS	TIPRANAVIR	CAPSULE;ORAL	250MG	Yes	Yes

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

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
N021814-001	APTIVUS	TIPRANAVIR	250MG	CAPSULE / ORAL		RLD, RS	2005-06-22

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`f41ea6bd6efb…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021814-001	6231887*PED	2019-01-27		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021814-001	5852195	2019-06-22		Drug substance	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021814-001	6147095	2019-10-29	U-670		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021814-001	5852195*PED	2019-12-22		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021814-001	6147095*PED	2020-04-29		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021814-001	6147095*PED	2020-04-29		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021814-001	6147095*PED	2020-04-29		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021814-001	6231887*PED	2019-01-27		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021814-001	5852195	2019-06-22		Drug substance	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021814-001	6147095	2019-10-29	U-670		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021814-001	5852195*PED	2019-12-22		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021814-001	6147095*PED	2020-04-29		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021814-001	6231887*PED	2019-01-27		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021814-001	5852195	2019-06-22		Drug substance	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021814-001	6147095	2019-10-29	U-670		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021814-001	5852195*PED	2019-12-22		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021814-001	6147095*PED	2020-04-29		Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021814-001	6231887*PED	2019-01-27		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021814-001	5852195	2019-06-22		Drug substance	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021814-001	6147095	2019-10-29	U-670		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021814-001	5852195*PED	2019-12-22		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021814-001	6147095*PED	2020-04-29		Pediatric extension	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
0597-0003	Aptivus	tipranavir	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0003	Aptivus	tipranavir	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0003	Aptivus	tipranavir	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0003	Aptivus	tipranavir	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0003	Aptivus	tipranavir	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78060	SUPPL	2024-04-04
78057	SUPPL	2024-04-03
63652	SUPPL	2020-06-22
63633	SUPPL	2020-06-19
54857	SUPPL	2018-07-06
54716	SUPPL	2018-06-28
45375	SUPPL	2016-09-23
45343	SUPPL	2016-09-20
37697	SUPPL	2015-04-07
6243	SUPPL	2015-04-01
37696	SUPPL	2014-04-08
28646	SUPPL	2014-04-08
28645	SUPPL	2012-02-27
37695	SUPPL	2012-02-22
6242	SUPPL	2011-04-07
16416	SUPPL	2011-04-06
6241	SUPPL	2010-09-07
16415	SUPPL	2010-08-16
24218	SUPPL	2010-05-12
21827	SUPPL	2010-05-12
37694	SUPPL	2010-05-07
28644	SUPPL	2010-05-03
37693	SUPPL	2009-06-24
6240	SUPPL	2009-06-24
37692	SUPPL	2008-06-26
28643	SUPPL	2008-06-26
28642	SUPPL	2007-10-10
16414	SUPPL	2007-10-10
6239	SUPPL	2007-05-29
28641	SUPPL	2006-08-18
28640	SUPPL	2006-08-18
37691	SUPPL	2006-08-14
16413	SUPPL	2006-08-14
21826	ORIG	2005-09-02
28639	ORIG	2005-06-24
37690	ORIG	2005-06-23
53417	ORIG	1900-01-01
53416	ORIG	1900-01-01
53415	ORIG	1900-01-01