Application 204806

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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 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	Approval date
A204806-001	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-25
A204806-002	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-06-25
A204806-003	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2018-06-25
A204806-004	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-06-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A204806-001	AB
A204806-002	AB
A204806-003	AB
A204806-004	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204806-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204806-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204806-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2018-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204806-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204806-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204806-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204806-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2018-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204806-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204806-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204806-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204806-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2018-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204806-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204806-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204806-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204806-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2018-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204806-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204806-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204806-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204806-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2018-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204806-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204806-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204806-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204806-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2018-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204806-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204806-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204806-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204806-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2018-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204806-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204806-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204806-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204806-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2018-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204806-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204806-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204806-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204806-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2018-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204806-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204806-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204806-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204806-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2018-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204806-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-06-25	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A204806-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204806-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204806-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204806-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204806-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204806-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204806-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204806-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204806-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204806-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204806-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204806-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204806-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204806-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204806-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204806-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204806-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204806-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204806-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204806-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204806-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204806-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204806-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204806-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204806-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204806-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204806-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204806-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204806-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204806-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204806-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204806-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204806-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204806-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204806-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204806-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204806-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204806-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204806-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204806-004	AB	1	`d06236e962d9…`

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
Atazanavir Sulfate	ATAZANAVIR	Aurobindo Pharma Limited	7fbea274-d6b5-4faa-bbf0-05fefab42114	2025-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204806 application number: ANDA204806 ndc (product): 65862-711 ndc (product): 65862-713 ndc (product): 65862-710 ndc (product): 65862-712

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6875	Atazanavir Sulfate	Atazanavir	Major Pharmaceuticals	ANDA	Current
0904-6875	Atazanavir Sulfate	Atazanavir	Major Pharmaceuticals	ANDA	Current
16714-860	Atazanavir Sulfate	Atazanavir	NorthStar Rx LLC	ANDA	Current
16714-860	Atazanavir Sulfate	Atazanavir	NorthStar Rx LLC	ANDA	Current
16714-860	Atazanavir Sulfate	Atazanavir	NorthStar Rx LLC	ANDA	Current
16714-861	Atazanavir Sulfate	Atazanavir	NorthStar Rx LLC	ANDA	Current
16714-861	Atazanavir Sulfate	Atazanavir	NorthStar Rx LLC	ANDA	Current
16714-861	Atazanavir Sulfate	Atazanavir	NorthStar Rx LLC	ANDA	Current
16714-862	Atazanavir Sulfate	Atazanavir	NorthStar Rx LLC	ANDA	Current
16714-862	Atazanavir Sulfate	Atazanavir	NorthStar Rx LLC	ANDA	Current
16714-862	Atazanavir Sulfate	Atazanavir	NorthStar Rx LLC	ANDA	Current
60687-399	Atazanavir Sulfate	Atazanavir	American Health Packaging	ANDA	Current
60687-399	Atazanavir Sulfate	Atazanavir	American Health Packaging	ANDA	Current
65862-710	Atazanavir Sulfate	Atazanavir	Aurobindo Pharma Limited	ANDA	Current
65862-710	Atazanavir Sulfate	Atazanavir	Aurobindo Pharma Limited	ANDA	Current
65862-710	Atazanavir Sulfate	Atazanavir	Aurobindo Pharma Limited	ANDA	Current
65862-711	Atazanavir Sulfate	Atazanavir	Aurobindo Pharma Limited	ANDA	Current
65862-711	Atazanavir Sulfate	Atazanavir	Aurobindo Pharma Limited	ANDA	Current
65862-711	Atazanavir Sulfate	Atazanavir	Aurobindo Pharma Limited	ANDA	Current
65862-712	Atazanavir Sulfate	Atazanavir	Aurobindo Pharma Limited	ANDA	Current
65862-712	Atazanavir Sulfate	Atazanavir	Aurobindo Pharma Limited	ANDA	Current
65862-712	Atazanavir Sulfate	Atazanavir	Aurobindo Pharma Limited	ANDA	Current
65862-713	Atazanavir Sulfate	Atazanavir	Aurobindo Pharma Limited	ANDA	Current
65862-713	Atazanavir Sulfate	Atazanavir	Aurobindo Pharma Limited	ANDA	Current
65862-713	Atazanavir Sulfate	Atazanavir	Aurobindo Pharma Limited	ANDA	Current
70518-1365	Atazanavir Sulfate	Atazanavir	REMEDYREPACK INC.	ANDA	Current
70518-1365	Atazanavir Sulfate	Atazanavir	REMEDYREPACK INC.	ANDA	Current
70518-1365	Atazanavir Sulfate	Atazanavir	REMEDYREPACK INC.	ANDA	Current
70518-1365	Atazanavir Sulfate	Atazanavir	REMEDYREPACK INC.	ANDA	Current
70518-1365	Atazanavir Sulfate	Atazanavir	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10397	ORIG	2014-02-04