Application 021567

Type: NDA
Sponsor: BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REYATAZ	ATAZANAVIR SULFATE	CAPSULE;ORAL	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	REYATAZ	ATAZANAVIR SULFATE	CAPSULE;ORAL	EQ 150MG BASE	Yes	No
003	REYATAZ	ATAZANAVIR SULFATE	CAPSULE;ORAL	EQ 200MG BASE	Yes	No
004	REYATAZ	ATAZANAVIR SULFATE	CAPSULE;ORAL	EQ 300MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021567-001	REYATAZ	ATAZANAVIR SULFATE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20
N021567-002	REYATAZ	ATAZANAVIR SULFATE	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20
N021567-003	REYATAZ	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD	2003-06-20
N021567-004	REYATAZ	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	2006-10-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021567-003	AB
N021567-004	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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	N021567-001	REYATAZ	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021567-002	REYATAZ	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021567-003	REYATAZ	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD	2003-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021567-004	REYATAZ	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	2006-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021567-001	REYATAZ	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021567-002	REYATAZ	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021567-003	REYATAZ	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD	2003-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021567-004	REYATAZ	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	2006-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021567-001	REYATAZ	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021567-002	REYATAZ	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021567-003	REYATAZ	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD	2003-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021567-004	REYATAZ	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	2006-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021567-001	REYATAZ	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021567-002	REYATAZ	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021567-003	REYATAZ	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD	2003-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021567-004	REYATAZ	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	2006-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021567-001	REYATAZ	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021567-002	REYATAZ	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021567-003	REYATAZ	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD	2003-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021567-004	REYATAZ	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	2006-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021567-001	REYATAZ	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021567-002	REYATAZ	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021567-003	REYATAZ	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD	2003-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021567-004	REYATAZ	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	2006-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021567-001	REYATAZ	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021567-002	REYATAZ	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021567-003	REYATAZ	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD	2003-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021567-004	REYATAZ	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	2006-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021567-001	REYATAZ	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021567-002	REYATAZ	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021567-003	REYATAZ	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD	2003-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021567-004	REYATAZ	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	2006-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021567-001	REYATAZ	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021567-002	REYATAZ	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021567-003	REYATAZ	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD	2003-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021567-004	REYATAZ	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	2006-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021567-001	REYATAZ	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021567-002	REYATAZ	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021567-003	REYATAZ	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD	2003-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021567-004	REYATAZ	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	2006-10-16	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 94 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021567-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021567-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021567-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021567-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021567-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021567-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021567-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021567-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021567-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021567-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021567-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021567-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021567-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021567-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021567-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021567-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021567-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021567-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021567-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021567-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021567-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021567-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021567-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021567-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021567-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021567-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021567-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021567-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021567-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021567-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021567-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021567-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021567-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021567-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021567-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021567-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021567-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021567-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021567-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021567-002	AB	1	`bb7c543d1eb4…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021567-001	6087383*PED	2019-06-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021567-002	6087383*PED	2019-06-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021567-003	6087383*PED	2019-06-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021567-004	6087383*PED	2019-06-21	Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021567-001	6087383*PED	2019-06-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021567-002	6087383*PED	2019-06-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021567-003	6087383*PED	2019-06-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021567-004	6087383*PED	2019-06-21	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021567-001	6087383*PED	2019-06-21	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021567-002	6087383*PED	2019-06-21	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021567-003	6087383*PED	2019-06-21	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021567-004	6087383*PED	2019-06-21	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021567-001	6087383*PED	2019-06-21	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021567-002	6087383*PED	2019-06-21	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021567-003	6087383*PED	2019-06-21	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021567-004	6087383*PED	2019-06-21	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
REYATAZ	ATAZANAVIR	E.R. Squibb & Sons, L.L.C.	165cff62-b284-4a27-a65d-9ec8a5bfcdd8	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021567 application number: NDA021567 ndc (product): 0003-3631 ndc (product): 0003-3624 ndc (product): 0003-3622

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0003-3622	REYATAZ	ATAZANAVIR	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3622	REYATAZ	ATAZANAVIR	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3622	REYATAZ	ATAZANAVIR	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3622	REYATAZ	ATAZANAVIR	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3622	REYATAZ	ATAZANAVIR	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3624	REYATAZ	ATAZANAVIR	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3624	REYATAZ	ATAZANAVIR	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3624	REYATAZ	ATAZANAVIR	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3624	REYATAZ	ATAZANAVIR	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3624	REYATAZ	ATAZANAVIR	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3631	REYATAZ	ATAZANAVIR	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3631	REYATAZ	ATAZANAVIR	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3631	REYATAZ	ATAZANAVIR	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3631	REYATAZ	ATAZANAVIR	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3631	REYATAZ	ATAZANAVIR	E.R. Squibb & Sons, L.L.C.	NDA	Current
50090-1007	REYATAZ	ATAZANAVIR	A-S Medication Solutions	NDA	Current
50090-1581	REYATAZ	ATAZANAVIR	A-S Medication Solutions	NDA	Current
59762-0408	ATAZANAVIR	ATAZANAVIR	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0409	ATAZANAVIR	ATAZANAVIR	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0410	ATAZANAVIR	ATAZANAVIR	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0410	ATAZANAVIR	ATAZANAVIR	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
67296-1236	REYATAZ	REYATAZ	RedPharm Drug, Inc.	NDA	Current
67296-1236	REYATAZ	REYATAZ	RedPharm Drug, Inc.	NDA	Current
67296-1236	REYATAZ	REYATAZ	RedPharm Drug, Inc.	NDA	Current
69189-3624	REYATAZ	ATAZANAVIR	Avera McKennan Hospital	NDA	Current
69189-3631	REYATAZ	ATAZANAVIR	Avera McKennan Hospital	NDA	Current
70518-0469	REYATAZ	ATAZANAVIR	REMEDYREPACK INC.	NDA	Current
70518-0469	REYATAZ	ATAZANAVIR	REMEDYREPACK INC.	NDA	Current
70518-0688	REYATAZ	ATAZANAVIR	REMEDYREPACK INC.	NDA	Current
70518-0688	REYATAZ	ATAZANAVIR	REMEDYREPACK INC.	NDA	Current
70518-0725	REYATAZ	ATAZANAVIR	REMEDYREPACK INC.	NDA	Current
70518-0725	REYATAZ	ATAZANAVIR	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80540	SUPPL	2024-12-10
80530	SUPPL	2024-12-06
76536	SUPPL	2023-11-08
76524	SUPPL	2023-11-08
74201	SUPPL	2023-05-10
64688	SUPPL	2020-09-25
64680	SUPPL	2020-09-25
53767	SUPPL	2018-04-20
53740	SUPPL	2018-04-19
50165	SUPPL	2017-10-24
50140	SUPPL	2017-10-23
48542	SUPPL	2017-05-25
48528	SUPPL	2017-05-25
45337	SUPPL	2016-09-20
45307	SUPPL	2016-09-15
37246	SUPPL	2015-12-10
28143	SUPPL	2015-09-28
42214	SUPPL	2015-07-20
24206	SUPPL	2015-04-07
21737	SUPPL	2015-04-07
15793	SUPPL	2015-04-02
28142	SUPPL	2015-04-01
5751	SUPPL	2015-02-27
21736	SUPPL	2014-08-05
28141	SUPPL	2014-06-03
15792	SUPPL	2014-06-03
37245	SUPPL	2013-08-21
15791	SUPPL	2013-08-21
28140	SUPPL	2013-08-20
5750	SUPPL	2013-08-20
51255	SUPPL	2013-05-20
28139	SUPPL	2013-02-04
51254	SUPPL	2013-01-29
28138	SUPPL	2012-03-16
15790	SUPPL	2012-03-16
37244	SUPPL	2012-02-24
5749	SUPPL	2012-02-23
51253	SUPPL	2011-11-22
28137	SUPPL	2011-10-19
37243	SUPPL	2011-10-17
51248	SUPPL	2011-08-02
28136	SUPPL	2011-02-10
15789	SUPPL	2011-02-09
37242	SUPPL	2010-05-03
5748	SUPPL	2010-04-29
28135	SUPPL	2010-01-28
28134	SUPPL	2010-01-25
37241	SUPPL	2010-01-24
15788	SUPPL	2009-11-23
51252	SUPPL	2009-04-29
37240	SUPPL	2008-10-03
28132	SUPPL	2008-10-02
37239	SUPPL	2008-08-26
5747	SUPPL	2008-08-20
51251	SUPPL	2008-05-01
28131	SUPPL	2008-03-28
37238	SUPPL	2008-03-27
15787	SUPPL	2008-02-25
28133	SUPPL	2008-02-22
28130	SUPPL	2008-01-09
15786	SUPPL	2008-01-08
37237	SUPPL	2007-03-31
28129	SUPPL	2007-03-31
51250	SUPPL	2006-12-04
5746	SUPPL	2006-10-23
37236	SUPPL	2006-10-18
28128	SUPPL	2006-08-14
28127	SUPPL	2006-08-14
37235	SUPPL	2006-08-11
15785	SUPPL	2006-08-11
28126	SUPPL	2006-01-30
37234	SUPPL	2006-01-25
28125	SUPPL	2005-07-21
15784	SUPPL	2005-07-21
37233	SUPPL	2004-10-08
5745	SUPPL	2004-10-08
15783	SUPPL	2004-07-07
5744	SUPPL	2004-07-07
37232	SUPPL	2004-04-05
5743	SUPPL	2004-03-19
42213	ORIG	2003-09-09
51249	SUPPL	2003-08-25
5742	ORIG	2003-08-06
37231	ORIG	2003-07-08
67191	SUPPL	1900-01-01
67190	SUPPL	1900-01-01
63866	ORIG	1900-01-01
63865	ORIG	1900-01-01
63864	ORIG	1900-01-01
63863	ORIG	1900-01-01
63862	ORIG	1900-01-01
63861	ORIG	1900-01-01
63860	ORIG	1900-01-01
63859	ORIG	1900-01-01
54095	SUPPL	1900-01-01
54094	SUPPL	1900-01-01
51747	SUPPL	1900-01-01
51746	SUPPL	1900-01-01
51743	SUPPL	1900-01-01
51742	SUPPL	1900-01-01