Application 075150

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLONAZEPAM	CLONAZEPAM	TABLET;ORAL	0.5MG	No	No
002	CLONAZEPAM	CLONAZEPAM	TABLET;ORAL	1MG	No	No
003	CLONAZEPAM	CLONAZEPAM	TABLET;ORAL	2MG	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
A075150-001	CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05
A075150-002	CLONAZEPAM	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05
A075150-003	CLONAZEPAM	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075150-001	AB
A075150-002	AB
A075150-003	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	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A075150-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075150-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075150-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075150-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075150-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075150-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075150-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075150-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075150-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075150-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075150-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075150-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075150-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075150-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075150-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075150-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075150-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075150-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075150-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075150-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075150-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075150-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075150-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075150-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075150-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075150-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075150-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075150-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075150-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075150-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075150-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075150-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075150-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075150-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075150-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075150-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075150-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075150-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075150-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075150-001	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	1fb0807c-dccd-47a5-ada4-91418c4f47f5	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	f613573a-3e8b-4abf-af69-0268f3d6f481	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	2606ecf9-3d71-4c1c-bfda-d7d98ffc6011	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	Proficient Rx LP	44f39aa8-a7bc-4e42-977c-31583e6388ae	2026-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	dec8b5b2-2490-4880-a8d1-707b57954297	2025-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	214e760b-c909-bd93-e063-6294a90ae74a	2024-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	20b3125e-4489-3c53-e063-6294a90a6539	2024-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	Advanced Rx Pharmacy of Tennessee, LLC	04db0fbe-7fa3-28af-e063-6294a90abbe6	2024-06-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	Aurobindo Pharma Limited	b1582eb7-af35-45d5-a52e-0e380d08527d	2023-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-1910	Clonazepam	clonazepam	Mylan Pharmaceuticals Inc	ANDA	Current
0378-1910	Clonazepam	clonazepam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1912	Clonazepam	clonazepam	Mylan Pharmaceuticals Inc	ANDA	Current
0378-1912	Clonazepam	clonazepam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1914	Clonazepam	clonazepam	Mylan Pharmaceuticals Inc	ANDA	Current
0378-1914	Clonazepam	clonazepam	Mylan Pharmaceuticals Inc.	ANDA	Current
50090-2965	Clonazepam	clonazepam	A-S Medication Solutions	ANDA	Current
50090-3375	Clonazepam	clonazepam	A-S Medication Solutions	ANDA	Current
50090-3375	Clonazepam	clonazepam	A-S Medication Solutions	ANDA	Current
51079-882	Clonazepam	clonazepam	Mylan Institutional Inc.	ANDA	Current
51079-883	Clonazepam	clonazepam	Mylan Institutional Inc.	ANDA	Current
55154-5452	Clonazepam	clonazepam	Cardinal Health	ANDA	Current
55154-5452	Clonazepam	clonazepam	Cardinal Health	ANDA	Current
55154-5462	Clonazepam	clonazepam	Cardinal Health	ANDA	Current
55154-5462	Clonazepam	clonazepam	Cardinal Health	ANDA	Current
55154-5462	Clonazepam	clonazepam	Cardinal Health	ANDA	Current
70518-0644	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-0644	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30774	ORIG	1998-10-05
22433	ORIG	1998-10-05