Application 210575

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

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

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A210575-001	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04
A210575-002	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04
A210575-003	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04

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 3 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A210575-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210575-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210575-003	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

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
70710-1050	ATAZANAVIR	ATAZANAVIR	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1050	ATAZANAVIR	ATAZANAVIR	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1051	ATAZANAVIR	ATAZANAVIR	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1051	ATAZANAVIR	ATAZANAVIR	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1052	ATAZANAVIR	ATAZANAVIR	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1052	ATAZANAVIR	ATAZANAVIR	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70771-1591	ATAZANAVIR	ATAZANAVIR	Zydus Lifesciences Limited	ANDA	Current
70771-1591	ATAZANAVIR	ATAZANAVIR	Cadila Healthcare Limited	ANDA	Current
70771-1592	ATAZANAVIR	ATAZANAVIR	Zydus Lifesciences Limited	ANDA	Current
70771-1592	ATAZANAVIR	ATAZANAVIR	Cadila Healthcare Limited	ANDA	Current
70771-1593	ATAZANAVIR	ATAZANAVIR	Zydus Lifesciences Limited	ANDA	Current
70771-1593	ATAZANAVIR	ATAZANAVIR	Cadila Healthcare Limited	ANDA	Current