Application 077171

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLONAZEPAM	CLONAZEPAM	TABLET, ORALLY DISINTEGRATING;ORAL	0.125MG	No	No
002	CLONAZEPAM	CLONAZEPAM	TABLET, ORALLY DISINTEGRATING;ORAL	0.25MG	No	No
003	CLONAZEPAM	CLONAZEPAM	TABLET, ORALLY DISINTEGRATING;ORAL	0.5MG	No	No
004	CLONAZEPAM	CLONAZEPAM	TABLET, ORALLY DISINTEGRATING;ORAL	1MG	No	Yes
005	CLONAZEPAM	CLONAZEPAM	TABLET, ORALLY DISINTEGRATING;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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077171-001	CLONAZEPAM	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03
A077171-002	CLONAZEPAM	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03
A077171-003	CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03
A077171-004	CLONAZEPAM	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2005-08-03
A077171-005	CLONAZEPAM	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077171-001	AB
A077171-002	AB
A077171-003	AB
A077171-004	AB
A077171-005	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077171-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077171-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077171-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077171-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2005-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077171-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077171-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077171-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077171-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077171-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2005-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077171-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077171-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077171-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077171-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077171-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2005-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077171-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077171-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077171-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077171-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077171-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2005-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077171-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077171-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077171-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077171-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077171-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2005-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077171-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077171-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077171-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077171-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077171-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2005-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077171-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077171-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077171-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077171-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077171-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2005-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077171-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077171-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077171-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077171-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077171-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2005-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077171-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 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	A077171-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077171-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077171-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077171-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077171-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077171-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077171-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077171-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077171-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077171-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077171-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077171-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077171-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077171-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077171-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077171-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077171-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077171-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077171-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077171-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077171-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077171-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077171-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077171-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077171-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077171-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077171-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077171-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077171-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077171-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077171-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077171-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077171-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077171-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077171-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077171-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077171-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077171-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077171-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077171-005	AB	1	`2680178bc6a6…`

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
Clonazepam	CLONAZEPAM	Par Health USA, LLC	1aef0069-80ea-483d-ac70-c8d485462c5b	2025-10-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077171 application number: ANDA077171 ndc (product): 49884-309 ndc (product): 49884-310 ndc (product): 49884-308 ndc (product): 49884-307 ndc (product): 49884-306

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-306	Clonazepam	clonazepam	Par Pharmaceutical, Inc.	ANDA	Current
49884-306	Clonazepam	clonazepam	Par Pharmaceutical, Inc.	ANDA	Current
49884-306	Clonazepam	clonazepam	Par Pharmaceutical, Inc.	ANDA	Current
49884-306	Clonazepam	clonazepam	Par Pharmaceutical, Inc.	ANDA	Current
49884-307	Clonazepam	clonazepam	Par Pharmaceutical, Inc.	ANDA	Current
49884-307	Clonazepam	clonazepam	Par Pharmaceutical, Inc.	ANDA	Current
49884-307	Clonazepam	clonazepam	Par Pharmaceutical, Inc.	ANDA	Current
49884-307	Clonazepam	clonazepam	Par Pharmaceutical, Inc.	ANDA	Current
49884-308	Clonazepam	clonazepam	Par Pharmaceutical, Inc.	ANDA	Current
49884-308	Clonazepam	clonazepam	Par Pharmaceutical, Inc.	ANDA	Current
49884-308	Clonazepam	clonazepam	Par Pharmaceutical, Inc.	ANDA	Current
49884-308	Clonazepam	clonazepam	Par Pharmaceutical, Inc.	ANDA	Current
49884-309	Clonazepam	clonazepam	Par Pharmaceutical, Inc.	ANDA	Current
49884-309	Clonazepam	clonazepam	Par Pharmaceutical, Inc.	ANDA	Current
49884-309	Clonazepam	clonazepam	Par Pharmaceutical, Inc.	ANDA	Current
49884-309	Clonazepam	clonazepam	Par Pharmaceutical, Inc.	ANDA	Current
49884-310	Clonazepam	clonazepam	Par Pharmaceutical, Inc.	ANDA	Current
49884-310	Clonazepam	clonazepam	Par Pharmaceutical, Inc.	ANDA	Current
49884-310	Clonazepam	clonazepam	Par Pharmaceutical, Inc.	ANDA	Current
49884-310	Clonazepam	clonazepam	Par Pharmaceutical, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31204	SUPPL	2009-12-24
31203	ORIG	2005-08-08