Application 021503

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 625MG 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
N021503-001	VIRACEPT	NELFINAVIR MESYLATE	EQ 625MG BASE	TABLET / ORAL		RLD, RS	2003-04-30

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	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021503-001	VIRACEPT	EQ 625MG BASE	TABLET / ORAL	RLD, RS	2003-04-30	`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): 021503 application number: NDA021503 ndc (product): 63010-027

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
53808-0809	Viracept	NELFINAVIR MESYLATE	State of Florida DOH Central Pharmacy	NDA	Current
63010-027	VIRACEPT	nelfinavir mesylate	AGOURON	NDA	Current
63010-027	VIRACEPT	nelfinavir mesylate	AGOURON	NDA	Current
63010-027	VIRACEPT	nelfinavir mesylate	AGOURON	NDA	Current
63010-027	VIRACEPT	nelfinavir mesylate	AGOURON	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66880	SUPPL	2021-03-25
66874	SUPPL	2021-03-25
45359	SUPPL	2016-09-22
45302	SUPPL	2016-09-20
15622	SUPPL	2015-04-07
27949	SUPPL	2015-03-31
15621	SUPPL	2013-06-04
27948	SUPPL	2013-05-31
27947	SUPPL	2012-04-11
37084	SUPPL	2012-04-09
5564	SUPPL	2012-02-27
15620	SUPPL	2012-02-24
15619	SUPPL	2011-03-04
27946	SUPPL	2011-02-28
37083	SUPPL	2010-05-03
15618	SUPPL	2010-05-03
27945	SUPPL	2010-04-28
5563	SUPPL	2010-04-28
5562	SUPPL	2008-11-26
27944	SUPPL	2008-02-14
15617	SUPPL	2008-02-14
21702	SUPPL	2007-08-06
21701	SUPPL	2007-08-06
15616	SUPPL	2007-08-02
27943	SUPPL	2007-01-08
37082	SUPPL	2006-12-28
21700	ORIG	2005-12-16
5561	SUPPL	2005-10-20
15615	SUPPL	2005-09-30
15614	SUPPL	2004-06-07
5560	SUPPL	2004-06-07
15612	SUPPL	2004-04-05
27941	SUPPL	2004-03-24
27942	SUPPL	2003-08-29
15613	SUPPL	2003-08-28
5559	ORIG	2003-05-29
15611	ORIG	2003-05-06