Application 075417

Type: ANDA
Sponsor: MYLAN

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	100MG	No	No
003	CLOZAPINE	CLOZAPINE	TABLET;ORAL	12.5MG	No	No
004	CLOZAPINE	CLOZAPINE	TABLET;ORAL	50MG	No	No
005	CLOZAPINE	CLOZAPINE	TABLET;ORAL	200MG	No	No

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

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	Approval date
A075417-001	CLOZAPINE	CLOZAPINE	25MG	TABLET / ORAL	AB	1999-05-27
A075417-002	CLOZAPINE	CLOZAPINE	100MG	TABLET / ORAL	AB	1999-05-27
A075417-003	CLOZAPINE	CLOZAPINE	12.5MG	TABLET / ORAL		2010-04-15
A075417-004	CLOZAPINE	CLOZAPINE	50MG	TABLET / ORAL	AB	2010-04-15
A075417-005	CLOZAPINE	CLOZAPINE	200MG	TABLET / ORAL	AB	2010-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075417-001	AB
A075417-002	AB
A075417-004	AB
A075417-005	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 6 · 210 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	A075417-001	CLOZAPINE	25MG	TABLET / ORAL	AB	1999-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075417-002	CLOZAPINE	100MG	TABLET / ORAL	AB	1999-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075417-003	CLOZAPINE	12.5MG	TABLET / ORAL		2010-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075417-004	CLOZAPINE	50MG	TABLET / ORAL	AB	2010-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075417-005	CLOZAPINE	200MG	TABLET / ORAL	AB	2010-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075417-001	CLOZAPINE	25MG	TABLET / ORAL	AB	1999-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075417-002	CLOZAPINE	100MG	TABLET / ORAL	AB	1999-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075417-003	CLOZAPINE	12.5MG	TABLET / ORAL		2010-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075417-004	CLOZAPINE	50MG	TABLET / ORAL	AB	2010-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075417-005	CLOZAPINE	200MG	TABLET / ORAL	AB	2010-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075417-001	CLOZAPINE	25MG	TABLET / ORAL	AB	1999-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075417-002	CLOZAPINE	100MG	TABLET / ORAL	AB	1999-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075417-003	CLOZAPINE	12.5MG	TABLET / ORAL		2010-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075417-004	CLOZAPINE	50MG	TABLET / ORAL	AB	2010-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075417-005	CLOZAPINE	200MG	TABLET / ORAL	AB	2010-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075417-001	CLOZAPINE	25MG	TABLET / ORAL	AB	1999-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075417-002	CLOZAPINE	100MG	TABLET / ORAL	AB	1999-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075417-003	CLOZAPINE	12.5MG	TABLET / ORAL		2010-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075417-004	CLOZAPINE	50MG	TABLET / ORAL	AB	2010-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075417-005	CLOZAPINE	200MG	TABLET / ORAL	AB	2010-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075417-001	CLOZAPINE	25MG	TABLET / ORAL	AB	1999-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075417-002	CLOZAPINE	100MG	TABLET / ORAL	AB	1999-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075417-003	CLOZAPINE	12.5MG	TABLET / ORAL		2010-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075417-004	CLOZAPINE	50MG	TABLET / ORAL	AB	2010-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075417-005	CLOZAPINE	200MG	TABLET / ORAL	AB	2010-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075417-001	CLOZAPINE	25MG	TABLET / ORAL	AB	1999-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075417-002	CLOZAPINE	100MG	TABLET / ORAL	AB	1999-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075417-003	CLOZAPINE	12.5MG	TABLET / ORAL		2010-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075417-004	CLOZAPINE	50MG	TABLET / ORAL	AB	2010-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075417-005	CLOZAPINE	200MG	TABLET / ORAL	AB	2010-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075417-001	CLOZAPINE	25MG	TABLET / ORAL	AB	1999-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075417-002	CLOZAPINE	100MG	TABLET / ORAL	AB	1999-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075417-003	CLOZAPINE	12.5MG	TABLET / ORAL		2010-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075417-004	CLOZAPINE	50MG	TABLET / ORAL	AB	2010-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075417-005	CLOZAPINE	200MG	TABLET / ORAL	AB	2010-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075417-001	CLOZAPINE	25MG	TABLET / ORAL	AB	1999-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075417-002	CLOZAPINE	100MG	TABLET / ORAL	AB	1999-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075417-003	CLOZAPINE	12.5MG	TABLET / ORAL		2010-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075417-004	CLOZAPINE	50MG	TABLET / ORAL	AB	2010-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075417-005	CLOZAPINE	200MG	TABLET / ORAL	AB	2010-04-15	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A075417-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075417-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075417-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075417-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075417-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075417-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075417-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075417-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075417-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075417-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075417-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075417-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075417-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075417-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075417-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075417-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075417-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075417-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075417-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075417-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075417-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075417-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075417-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075417-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075417-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075417-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075417-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075417-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075417-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075417-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075417-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075417-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075417-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075417-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075417-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075417-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075417-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075417-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075417-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075417-005	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clozapine	CLOZAPINE	Mylan Pharmaceuticals Inc.	883b5d43-0339-7dc1-f775-93791fb9b978	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075417 application number: ANDA075417 ndc (product): 0378-0972 ndc (product): 0378-0860 ndc (product): 0378-0973 ndc (product): 0378-0825
Clozapine	CLOZAPINE	Safecor Health LLC	0fa59238-f0a6-4d00-9d8d-df2a43718fc1	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075417 application number: ANDA075417
Clozapine	CLOZAPINE	Mylan Institutional Inc.	d5c8a456-6f3c-4963-b321-4ed746f690e4	2025-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075417 application number: ANDA075417 ndc (product): 51079-749 ndc (product): 51079-921 ndc (product): 51079-922

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0825	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0825	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0825	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0825	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0825	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0825	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0825	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0825	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0860	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0860	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0860	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0860	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0860	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0860	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0860	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0860	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0972	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0972	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0972	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0972	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0972	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0972	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0972	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0972	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0973	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0973	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0973	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0973	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0973	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0973	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0973	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0973	Clozapine	clozapine	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-749	Clozapine	clozapine	Mylan Institutional Inc.	ANDA	Current
51079-749	Clozapine	clozapine	Mylan Institutional Inc.	ANDA	Current
51079-749	Clozapine	clozapine	Mylan Institutional Inc.	ANDA	Current
51079-749	Clozapine	clozapine	Mylan Institutional Inc.	ANDA	Current
51079-921	Clozapine	clozapine	Mylan Institutional Inc.	ANDA	Current
51079-921	Clozapine	clozapine	Mylan Institutional Inc.	ANDA	Current
51079-921	Clozapine	clozapine	Mylan Institutional Inc.	ANDA	Current
51079-921	Clozapine	clozapine	Mylan Institutional Inc.	ANDA	Current
51079-922	Clozapine	clozapine	Mylan Institutional Inc.	ANDA	Current
51079-922	Clozapine	clozapine	Mylan Institutional Inc.	ANDA	Current
51079-922	Clozapine	clozapine	Mylan Institutional Inc.	ANDA	Current
51079-922	Clozapine	clozapine	Mylan Institutional Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44526	ORIG	2015-09-16
30878	SUPPL	2010-04-28
8662	SUPPL	2010-04-28
8661	SUPPL	2010-04-28
42993	ORIG	2003-08-04
30877	ORIG	1999-05-27