Application 020779

Type: NDA
Sponsor: AGOURON PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIRACEPT	NELFINAVIR MESYLATE	TABLET;ORAL	EQ 250MG BASE	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
N020779-001	VIRACEPT	NELFINAVIR MESYLATE	EQ 250MG BASE	TABLET / ORAL		RLD, RS	1997-03-14

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	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020779-001	VIRACEPT	EQ 250MG BASE	TABLET / ORAL	RLD, RS	1997-03-14	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VIRACEPT	NELFINAVIR MESYLATE	AGOURON	e72c2bc6-9462-4a2e-8e1d-b97592376cbd	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020779 application number: NDA020779 ndc (product): 63010-010

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52959-289	VIRACEPT	nelfinavir mesylate	H.J. Harkins Company, Inc.	NDA	Current
55289-477	VIRACEPT	nelfinavir mesylate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
63010-010	VIRACEPT	nelfinavir mesylate	AGOURON	NDA	Current
63010-010	VIRACEPT	nelfinavir mesylate	AGOURON	NDA	Current
63010-010	VIRACEPT	nelfinavir mesylate	AGOURON	NDA	Current
63010-010	VIRACEPT	nelfinavir mesylate	AGOURON	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66879	SUPPL	2021-03-25
66873	SUPPL	2021-03-25
45361	SUPPL	2016-09-22
45303	SUPPL	2016-09-15
35337	SUPPL	2015-04-07
3332	SUPPL	2015-03-31
13410	SUPPL	2013-06-04
3331	SUPPL	2013-05-31
25797	SUPPL	2012-04-11
35335	SUPPL	2012-04-09
25798	SUPPL	2012-02-27
35336	SUPPL	2012-02-24
13409	SUPPL	2011-03-10
25796	SUPPL	2011-02-28
35334	SUPPL	2010-05-03
13408	SUPPL	2010-05-03
25795	SUPPL	2010-04-28
3330	SUPPL	2010-04-28
25794	SUPPL	2008-11-26
35333	SUPPL	2008-02-14
3329	SUPPL	2008-02-14
35332	SUPPL	2007-12-03
41692	SUPPL	2007-08-06
41690	SUPPL	2007-08-06
20941	SUPPL	2007-08-06
20940	SUPPL	2007-08-06
20939	SUPPL	2007-08-06
20938	SUPPL	2007-08-06
25793	SUPPL	2007-01-08
35331	SUPPL	2006-12-28
25792	SUPPL	2005-10-20
35330	SUPPL	2005-09-30
13407	SUPPL	2004-06-07
3328	SUPPL	2004-06-07
13406	SUPPL	2004-04-05
25791	SUPPL	2004-03-24
25790	SUPPL	2003-08-29
35329	SUPPL	2003-08-28
3327	SUPPL	2003-07-30
41691	SUPPL	2003-04-30
25787	SUPPL	2003-04-30
25786	SUPPL	2003-04-30
20937	SUPPL	2003-04-30
35328	SUPPL	2003-04-04
25789	SUPPL	2002-02-05
3326	SUPPL	2002-02-05
25788	SUPPL	2001-04-11
20936	ORIG	1997-03-14