Application 206433

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOZAPINE	CLOZAPINE	TABLET;ORAL	25MG	No	No
002	CLOZAPINE	CLOZAPINE	TABLET;ORAL	50MG	No	No
003	CLOZAPINE	CLOZAPINE	TABLET;ORAL	100MG	No	No
004	CLOZAPINE	CLOZAPINE	TABLET;ORAL	200MG	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
A206433-001	CLOZAPINE	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29
A206433-002	CLOZAPINE	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29
A206433-003	CLOZAPINE	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29
A206433-004	CLOZAPINE	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206433-001	AB
A206433-002	AB
A206433-003	AB
A206433-004	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	A206433-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206433-002	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206433-003	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206433-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206433-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206433-002	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206433-003	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206433-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206433-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206433-002	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206433-003	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206433-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206433-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206433-002	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206433-003	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206433-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206433-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206433-002	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206433-003	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206433-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206433-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206433-002	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206433-003	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206433-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206433-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206433-002	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206433-003	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206433-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206433-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206433-002	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206433-003	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206433-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206433-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206433-002	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206433-003	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206433-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206433-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206433-002	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206433-003	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206433-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29	`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	A206433-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206433-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206433-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206433-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206433-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206433-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206433-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206433-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206433-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206433-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206433-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206433-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206433-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206433-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206433-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206433-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206433-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206433-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206433-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206433-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206433-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206433-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206433-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206433-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206433-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206433-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206433-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206433-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206433-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206433-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206433-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206433-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206433-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206433-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206433-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206433-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206433-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206433-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206433-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206433-004	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLOZAPINE	CLOZAPINE	Cardinal Health 107, LLC	7c748f8a-73ce-4bd3-aa30-9c66657f06ec	2026-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206433 application number: ANDA206433 ndc (product): 55154-3568
CLOZAPINE	CLOZAPINE	Major Pharmaceuticals	9db7aefb-f607-4158-a310-181e631bc648	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206433 application number: ANDA206433 ndc (product): 0904-7089 ndc (product): 0904-7087 ndc (product): 0904-7088
CLOZAPINE	CLOZAPINE	Aurobindo Pharma Limited	5021d643-32d2-4167-b5d8-90870e68a787	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206433 application number: ANDA206433 ndc (product): 65862-847 ndc (product): 65862-846 ndc (product): 65862-844 ndc (product): 65862-845
Clozapine	CLOZAPINE	American Health Packaging	d36c298b-7292-46e0-898f-43d3e11c3cf4	2025-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206433 application number: ANDA206433 ndc (product): 60687-404 ndc (product): 60687-548 ndc (product): 60687-426 ndc (product): 60687-415

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7087	CLOZAPINE	CLOZAPINE	Major Pharmaceuticals	ANDA	Current
0904-7088	CLOZAPINE	CLOZAPINE	Major Pharmaceuticals	ANDA	Current
0904-7089	CLOZAPINE	CLOZAPINE	Major Pharmaceuticals	ANDA	Current
55154-3568	CLOZAPINE	CLOZAPINE	Cardinal Health	ANDA	Current
60687-404	CLOZAPINE	CLOZAPINE	American Health Packaging	ANDA	Current
60687-404	Clozapine	Clozapine	American Health Packaging	ANDA	Current
60687-404	Clozapine	Clozapine	American Health Packaging	ANDA	Current
60687-404	Clozapine	Clozapine	American Health Packaging	ANDA	Current
60687-415	CLOZAPINE	CLOZAPINE	American Health Packaging	ANDA	Current
60687-415	Clozapine	Clozapine	American Health Packaging	ANDA	Current
60687-415	Clozapine	Clozapine	American Health Packaging	ANDA	Current
60687-415	Clozapine	Clozapine	American Health Packaging	ANDA	Current
60687-426	CLOZAPINE	CLOZAPINE	American Health Packaging	ANDA	Current
60687-426	Clozapine	Clozapine	American Health Packaging	ANDA	Current
60687-426	Clozapine	Clozapine	American Health Packaging	ANDA	Current
60687-426	Clozapine	Clozapine	American Health Packaging	ANDA	Current
60687-548	Clozapine	Clozapine	American Health Packaging	ANDA	Current
60687-548	Clozapine	Clozapine	American Health Packaging	ANDA	Current
60687-548	Clozapine	Clozapine	American Health Packaging	ANDA	Current
65862-844	CLOZAPINE	CLOZAPINE	Aurobindo Pharma Limited	ANDA	Current
65862-844	CLOZAPINE	CLOZAPINE	Aurobindo Pharma Limited	ANDA	Current
65862-844	CLOZAPINE	CLOZAPINE	Aurobindo Pharma Limited	ANDA	Current
65862-844	CLOZAPINE	CLOZAPINE	Aurobindo Pharma Limited	ANDA	Current
65862-845	CLOZAPINE	CLOZAPINE	Aurobindo Pharma Limited	ANDA	Current
65862-845	CLOZAPINE	CLOZAPINE	Aurobindo Pharma Limited	ANDA	Current
65862-845	CLOZAPINE	CLOZAPINE	Aurobindo Pharma Limited	ANDA	Current
65862-845	CLOZAPINE	CLOZAPINE	Aurobindo Pharma Limited	ANDA	Current
65862-846	CLOZAPINE	CLOZAPINE	Aurobindo Pharma Limited	ANDA	Current
65862-846	CLOZAPINE	CLOZAPINE	Aurobindo Pharma Limited	ANDA	Current
65862-846	CLOZAPINE	CLOZAPINE	Aurobindo Pharma Limited	ANDA	Current
65862-846	CLOZAPINE	CLOZAPINE	Aurobindo Pharma Limited	ANDA	Current
65862-847	CLOZAPINE	CLOZAPINE	Aurobindo Pharma Limited	ANDA	Current
65862-847	CLOZAPINE	CLOZAPINE	Aurobindo Pharma Limited	ANDA	Current
65862-847	CLOZAPINE	CLOZAPINE	Aurobindo Pharma Limited	ANDA	Current
65862-847	CLOZAPINE	CLOZAPINE	Aurobindo Pharma Limited	ANDA	Current
70518-3357	CLOZAPINE	CLOZAPINE	REMEDYREPACK INC.	ANDA	Current
70518-3391	CLOZAPINE	CLOZAPINE	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76366	ORIG	2023-11-06
46027	ORIG	2016-12-06