Application 090308

Type: ANDA
Sponsor: BARR LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOZAPINE	CLOZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	25MG	No	No
002	CLOZAPINE	CLOZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	100MG	No	Yes
003	CLOZAPINE	CLOZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	12.5MG	No	No
004	CLOZAPINE	CLOZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	150MG	No	No
005	CLOZAPINE	CLOZAPINE	TABLET, ORALLY DISINTEGRATING;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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090308-001	CLOZAPINE	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25
A090308-002	CLOZAPINE	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-11-25
A090308-003	CLOZAPINE	CLOZAPINE	12.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-04-09
A090308-004	CLOZAPINE	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25
A090308-005	CLOZAPINE	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A090308-001	AB
A090308-002	AB
A090308-003	AB
A090308-004	AB
A090308-005	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 · 149 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090308-001	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090308-002	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090308-003	CLOZAPINE	12.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090308-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090308-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090308-001	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090308-002	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090308-003	CLOZAPINE	12.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090308-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090308-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090308-001	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090308-002	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090308-003	CLOZAPINE	12.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090308-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090308-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090308-001	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090308-002	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090308-003	CLOZAPINE	12.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090308-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090308-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090308-001	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090308-002	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090308-003	CLOZAPINE	12.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090308-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090308-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090308-001	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090308-002	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090308-003	CLOZAPINE	12.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-04-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090308-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090308-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090308-001	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090308-002	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090308-003	CLOZAPINE	12.5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2018-04-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090308-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090308-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090308-001	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090308-002	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090308-003	CLOZAPINE	12.5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2018-04-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090308-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090308-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-11-25	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 118 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	A090308-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090308-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090308-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090308-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090308-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090308-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090308-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090308-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090308-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090308-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090308-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090308-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090308-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090308-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090308-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090308-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090308-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090308-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090308-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090308-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090308-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090308-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090308-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090308-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090308-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090308-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090308-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090308-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090308-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090308-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090308-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090308-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090308-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090308-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090308-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090308-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090308-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090308-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090308-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090308-002	AB	1	`d8e5a09893c0…`

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
Clozapine	CLOZAPINE	Teva Pharmaceuticals USA, Inc.	6fccf4f7-2e30-4272-9800-225aaef20584	2025-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090308 application number: ANDA090308 ndc (product): 0093-5419 ndc (product): 0093-5416 ndc (product): 0093-5417

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5416	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5416	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5416	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5416	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5416	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5417	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5417	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5417	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5417	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5417	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5419	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5419	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5419	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5419	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5419	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54157	ORIG	2018-05-11
44549	ORIG	2015-11-30
9265	ORIG	2015-11-30