Application 208961

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	CAPSULE;ORAL	25MG	No	No
002	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	CAPSULE;ORAL	50MG	No	No
003	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	CAPSULE;ORAL	75MG	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
A208961-001	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2017-12-27
A208961-002	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2017-12-27
A208961-003	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2017-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208961-001	AB
A208961-002	AB
A208961-003	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	A208961-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2017-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208961-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2017-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208961-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2017-12-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208961-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2017-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208961-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2017-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208961-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2017-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208961-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2017-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208961-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2017-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208961-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2017-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208961-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2017-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208961-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2017-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208961-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2017-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208961-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2017-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208961-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2017-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208961-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2017-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208961-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2017-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208961-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2017-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208961-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2017-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208961-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2017-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208961-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2017-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208961-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2017-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208961-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2017-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208961-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2017-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208961-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2017-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208961-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2017-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208961-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2017-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208961-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2017-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208961-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2017-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208961-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2017-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208961-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2017-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208961-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2017-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208961-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2017-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208961-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2017-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208961-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2017-12-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208961-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2017-12-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208961-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2017-12-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208961-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2017-12-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208961-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2017-12-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208961-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2017-12-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208961-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2017-12-27	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A208961-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208961-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208961-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208961-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208961-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208961-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208961-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208961-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208961-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208961-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208961-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208961-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208961-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208961-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208961-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208961-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208961-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208961-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208961-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208961-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208961-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208961-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208961-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208961-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208961-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208961-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208961-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208961-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208961-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208961-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208961-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208961-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208961-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208961-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208961-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208961-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208961-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208961-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208961-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208961-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clomipramine Hydrochloride	CLOMIPRAMINE HYDROCHLORIDE	Northstar Rx LLC.	b1809cb2-c6a8-451a-b692-506456c4efc3	2022-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208961 application number: ANDA208961 ndc (product): 16714-850 ndc (product): 16714-849 ndc (product): 16714-851

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-849	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Northstar Rx LLC.	ANDA	Current
16714-849	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Northstar Rx LLC.	ANDA	Current
16714-849	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Northstar Rx LLC.	ANDA	Current
16714-850	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Northstar Rx LLC.	ANDA	Current
16714-850	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Northstar Rx LLC.	ANDA	Current
16714-850	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Northstar Rx LLC.	ANDA	Current
16714-851	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Northstar Rx LLC.	ANDA	Current
16714-851	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Northstar Rx LLC.	ANDA	Current
16714-851	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Northstar Rx LLC.	ANDA	Current
70710-1065	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1065	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1065	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1065	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1065	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1066	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1066	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1066	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1066	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1066	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1067	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1067	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1067	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1067	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1067	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1012	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1012	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1012	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1012	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1013	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1013	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1013	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1013	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1014	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1014	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1014	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1014	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Cadila Healthcare Limited	ANDA	Current