Application 209717

Type: ANDA
Sponsor: AMNEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	CAPSULE;ORAL	EQ 100MG BASE	No	No
002	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	CAPSULE;ORAL	EQ 150MG BASE	No	No
003	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	CAPSULE;ORAL	EQ 200MG BASE	No	No
004	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	CAPSULE;ORAL	EQ 300MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A209717-001	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL	2020-06-01
A209717-002	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-01
A209717-003	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-01
A209717-004	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-01

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 2 of 4 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209717-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2020-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209717-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209717-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2020-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209717-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2020-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209717-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2020-06-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209717-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL		2020-06-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209717-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL		2020-06-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209717-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL		2020-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209717-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2020-06-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209717-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL		2020-06-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209717-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL		2020-06-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209717-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL		2020-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209717-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2020-06-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209717-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-06-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209717-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2020-06-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209717-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2020-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209717-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2020-06-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209717-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-06-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209717-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2020-06-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209717-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2020-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209717-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2020-06-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209717-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-06-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209717-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2020-06-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209717-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2020-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209717-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2020-06-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209717-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-06-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209717-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2020-06-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209717-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2020-06-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209717-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2020-06-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209717-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-06-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209717-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2020-06-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209717-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2020-06-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209717-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2020-06-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209717-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-06-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209717-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2020-06-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209717-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2020-06-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209717-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2020-06-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209717-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-06-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209717-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2020-06-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209717-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2020-06-01	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209717-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209717-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209717-004	AB	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209717-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209717-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209717-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209717-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209717-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209717-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209717-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209717-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209717-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209717-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209717-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209717-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209717-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209717-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209717-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209717-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209717-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209717-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209717-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209717-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209717-004	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209717-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209717-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209717-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209717-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209717-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209717-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209717-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209717-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209717-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209717-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209717-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209717-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209717-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209717-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209717-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209717-002	AB	1	`c0c555d07b60…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atazanavir Sulfate	ATAZANAVIR	Aurobindo Pharma Limited	7fbea274-d6b5-4faa-bbf0-05fefab42114	2025-08-06	Warnings, Adverse reactions	Name fallback brand name: Atazanavir Sulfate
Atazanavir Sulfate	ATAZANAVIR SULFATE	Teva Pharmaceuticals USA, Inc.	654b7e08-33d8-47e7-b37f-3681e79c7b8b	2024-12-30	Warnings, Adverse reactions	Name fallback brand name: Atazanavir Sulfate generic name: ATAZANAVIR SULFATE

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69238-1135	Atazanavir	Atazanavir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1135	Atazanavir	Atazanavir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1135	Atazanavir	Atazanavir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1136	Atazanavir	Atazanavir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1136	Atazanavir	Atazanavir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1136	Atazanavir	Atazanavir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1137	Atazanavir	Atazanavir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1137	Atazanavir	Atazanavir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1137	Atazanavir	Atazanavir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1138	Atazanavir	Atazanavir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1138	Atazanavir	Atazanavir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1138	Atazanavir	Atazanavir	Amneal Pharmaceuticals NY LLC	ANDA	Current