Application 211033

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

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	No
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	Approval date
A211033-001	CLONAZEPAM	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28
A211033-002	CLONAZEPAM	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28
A211033-003	CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28
A211033-004	CLONAZEPAM	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28
A211033-005	CLONAZEPAM	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211033-001	AB
A211033-002	AB
A211033-003	AB
A211033-004	AB
A211033-005	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	A211033-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211033-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211033-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211033-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211033-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211033-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211033-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211033-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211033-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211033-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211033-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211033-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211033-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211033-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211033-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211033-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211033-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211033-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211033-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211033-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211033-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211033-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211033-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211033-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211033-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211033-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211033-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211033-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211033-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211033-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211033-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211033-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211033-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211033-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211033-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211033-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211033-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211033-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211033-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211033-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`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	A211033-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211033-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211033-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211033-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211033-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211033-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211033-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211033-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211033-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211033-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211033-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211033-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211033-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211033-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211033-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211033-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211033-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211033-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211033-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211033-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211033-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211033-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211033-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211033-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211033-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211033-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211033-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211033-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211033-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211033-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211033-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211033-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211033-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211033-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211033-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211033-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211033-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211033-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211033-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211033-005	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ecb28fcb-f0d1-4558-b460-ecabd0f6009e	2025-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211033 application number: ANDA211033 ndc (product): 62332-364 ndc (product): 62332-366 ndc (product): 62332-368 ndc (product): 62332-367 ndc (product): 62332-365
CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Limited	43ee20ce-0015-413c-b230-822e390b02f7	2023-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211033 application number: ANDA211033 ndc (product): 46708-366 ndc (product): 46708-365 ndc (product): 46708-364 ndc (product): 46708-367 ndc (product): 46708-368

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-364	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Limited	ANDA	Current
46708-365	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Limited	ANDA	Current
46708-366	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Limited	ANDA	Current
46708-367	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Limited	ANDA	Current
46708-368	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Limited	ANDA	Current
62332-364	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-364	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-364	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-364	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-364	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-364	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-365	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-365	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-365	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-365	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-365	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-365	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-366	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-366	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-366	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-366	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-366	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-366	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-367	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-367	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-367	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-367	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-367	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-367	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-368	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-368	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-368	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-368	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-368	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-368	CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ANDA	Current