Application 076809

Type: ANDA
Sponsor: IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOZAPINE	CLOZAPINE	TABLET;ORAL	200MG	No	No
002	CLOZAPINE	CLOZAPINE	TABLET;ORAL	100MG	No	No
003	CLOZAPINE	CLOZAPINE	TABLET;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	TE codes	Approval date
A076809-001	CLOZAPINE	CLOZAPINE	200MG	TABLET / ORAL	AB	2005-12-16
A076809-002	CLOZAPINE	CLOZAPINE	100MG	TABLET / ORAL	AB	2005-12-16
A076809-003	CLOZAPINE	CLOZAPINE	50MG	TABLET / ORAL	AB	2005-12-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A076809-001	AB
A076809-002	AB
A076809-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A076809-001	CLOZAPINE	200MG	TABLET / ORAL	AB	2005-12-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076809-002	CLOZAPINE	100MG	TABLET / ORAL	AB	2005-12-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076809-003	CLOZAPINE	50MG	TABLET / ORAL	AB	2005-12-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076809-001	CLOZAPINE	200MG	TABLET / ORAL	AB	2005-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076809-002	CLOZAPINE	100MG	TABLET / ORAL	AB	2005-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076809-003	CLOZAPINE	50MG	TABLET / ORAL	AB	2005-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076809-001	CLOZAPINE	200MG	TABLET / ORAL	AB	2005-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076809-002	CLOZAPINE	100MG	TABLET / ORAL	AB	2005-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076809-003	CLOZAPINE	50MG	TABLET / ORAL	AB	2005-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076809-001	CLOZAPINE	200MG	TABLET / ORAL	AB	2005-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076809-002	CLOZAPINE	100MG	TABLET / ORAL	AB	2005-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076809-003	CLOZAPINE	50MG	TABLET / ORAL	AB	2005-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076809-001	CLOZAPINE	200MG	TABLET / ORAL	AB	2005-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076809-002	CLOZAPINE	100MG	TABLET / ORAL	AB	2005-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076809-003	CLOZAPINE	50MG	TABLET / ORAL	AB	2005-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076809-001	CLOZAPINE	200MG	TABLET / ORAL	AB	2005-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076809-002	CLOZAPINE	100MG	TABLET / ORAL	AB	2005-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076809-003	CLOZAPINE	50MG	TABLET / ORAL	AB	2005-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076809-001	CLOZAPINE	200MG	TABLET / ORAL	AB	2005-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076809-002	CLOZAPINE	100MG	TABLET / ORAL	AB	2005-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076809-003	CLOZAPINE	50MG	TABLET / ORAL	AB	2005-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076809-001	CLOZAPINE	200MG	TABLET / ORAL	AB	2005-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076809-002	CLOZAPINE	100MG	TABLET / ORAL	AB	2005-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076809-003	CLOZAPINE	50MG	TABLET / ORAL	AB	2005-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076809-001	CLOZAPINE	200MG	TABLET / ORAL	AB	2005-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076809-002	CLOZAPINE	100MG	TABLET / ORAL	AB	2005-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076809-003	CLOZAPINE	50MG	TABLET / ORAL	AB	2005-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076809-001	CLOZAPINE	200MG	TABLET / ORAL	AB	2005-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076809-002	CLOZAPINE	100MG	TABLET / ORAL	AB	2005-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076809-003	CLOZAPINE	50MG	TABLET / ORAL	AB	2005-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076809-001	CLOZAPINE	200MG	TABLET / ORAL	AB	2005-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076809-002	CLOZAPINE	100MG	TABLET / ORAL	AB	2005-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076809-003	CLOZAPINE	50MG	TABLET / ORAL	AB	2005-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076809-001	CLOZAPINE	200MG	TABLET / ORAL	AB	2005-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076809-002	CLOZAPINE	100MG	TABLET / ORAL	AB	2005-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076809-003	CLOZAPINE	50MG	TABLET / ORAL	AB	2005-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076809-001	CLOZAPINE	200MG	TABLET / ORAL	AB	2005-12-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076809-002	CLOZAPINE	100MG	TABLET / ORAL	AB	2005-12-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076809-003	CLOZAPINE	50MG	TABLET / ORAL	AB	2005-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076809-001	CLOZAPINE	200MG	TABLET / ORAL	AB	2005-12-16	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076809-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076809-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076809-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076809-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076809-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076809-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076809-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076809-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076809-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076809-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076809-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076809-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076809-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076809-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076809-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076809-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076809-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076809-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076809-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076809-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076809-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076809-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076809-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076809-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076809-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076809-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076809-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076809-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076809-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076809-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076809-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076809-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076809-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076809-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076809-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076809-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076809-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076809-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076809-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076809-001	AB	1	`1e350fbaab3a…`

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLOZAPINE	CLOZAPINE	NorthStar Rx LLC	61fe53d5-ed5c-4e45-9189-709d08d386cb	2026-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CLOZAPINE generic name: CLOZAPINE
CLOZAPINE	CLOZAPINE	Cardinal Health 107, LLC	7c748f8a-73ce-4bd3-aa30-9c66657f06ec	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CLOZAPINE generic name: CLOZAPINE
Clozapine	CLOZAPINE	Mylan Pharmaceuticals Inc.	883b5d43-0339-7dc1-f775-93791fb9b978	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clozapine generic name: CLOZAPINE
Clozapine	CLOZAPINE	Safecor Health, LLC	09231d80-6343-4a34-bd5b-100c547fd3c9	2026-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clozapine generic name: CLOZAPINE
Clozapine	CLOZAPINE	Safecor Health LLC	0fa59238-f0a6-4d00-9d8d-df2a43718fc1	2026-03-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clozapine generic name: CLOZAPINE
CLOZAPINE	CLOZAPINE	Major Pharmaceuticals	9db7aefb-f607-4158-a310-181e631bc648	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CLOZAPINE generic name: CLOZAPINE
CLOZAPINE	CLOZAPINE	Aurobindo Pharma Limited	5021d643-32d2-4167-b5d8-90870e68a787	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CLOZAPINE generic name: CLOZAPINE
Clozapine	CLOZAPINE	Mylan Institutional Inc.	d5c8a456-6f3c-4963-b321-4ed746f690e4	2025-11-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clozapine generic name: CLOZAPINE
Clozapine	CLOZAPINE	Accord Healthcare Inc.	25c0c6d5-f7b0-48e4-e054-00144ff8d46c	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clozapine generic name: CLOZAPINE
Clozapine	CLOZAPINE	American Health Packaging	d36c298b-7292-46e0-898f-43d3e11c3cf4	2025-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clozapine generic name: CLOZAPINE
Clozapine	CLOZAPINE	Mylan Pharmaceuticals Inc.	9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b219	2025-08-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clozapine generic name: CLOZAPINE
Clozapine	CLOZAPINE	Mylan Institutional Inc.	976be6e3-a9db-49c6-9b02-1ab168cf17b1	2025-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clozapine generic name: CLOZAPINE
Clozapine	CLOZAPINE	Teva Pharmaceuticals USA, Inc.	6fccf4f7-2e30-4272-9800-225aaef20584	2025-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clozapine generic name: CLOZAPINE
VERSACLOZ	CLOZAPINE	TruPharma LLC	2592c9a8-fd74-4e0d-a895-b07b014cf355	2025-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOZAPINE
Clozaril	CLOZAPINE	HLS Therapeutics (USA), Inc.	90876802-0e3a-44c9-9ff7-1754dfbe736a	2025-06-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOZAPINE
Clozapine	CLOZAPINE	Aurobindo Pharma Limited	caf2d4a6-2a23-4992-a807-560c4204afc4	2025-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clozapine generic name: CLOZAPINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-4404	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4404	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4404	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4404	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4404	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4404	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4404	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4404	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4404	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4404	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4404	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4405	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4405	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4405	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4405	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4405	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4405	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4405	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4405	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4405	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4405	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24059	ORIG	2015-09-16