Application 074694

Type: ANDA
Sponsor: TARO

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
A074694-001	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31
A074694-002	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31
A074694-003	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074694-001	AB
A074694-002	AB
A074694-003	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	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`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	A074694-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074694-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074694-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074694-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074694-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074694-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074694-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074694-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074694-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074694-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074694-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074694-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074694-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074694-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074694-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074694-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074694-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074694-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074694-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074694-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074694-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074694-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074694-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074694-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074694-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074694-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074694-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074694-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074694-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074694-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074694-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074694-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074694-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074694-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074694-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074694-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074694-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074694-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074694-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074694-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	Major Pharmaceuticals	eff91018-5a5e-4426-96ae-71ecd82273b7	2025-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074694 application number: ANDA074694 ndc (product): 0904-7038 ndc (product): 0904-7039
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	fa2eb38c-b155-0d53-e053-6294a90a1d29	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074694 application number: ANDA074694
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	db752dbd-be41-4cdd-8a13-ed1ff9ef7461	2025-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074694 application number: ANDA074694 ndc (product): 51672-4012 ndc (product): 51672-4013 ndc (product): 51672-4011
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	American Health Packaging	1809bcb4-5fcc-45ca-986a-4fa5edcd4b5e	2024-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074694 application number: ANDA074694 ndc (product): 68084-790 ndc (product): 68084-818

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7038	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7038	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7039	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7039	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	Major Pharmaceuticals	ANDA	Current
51672-4011	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4011	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4012	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4012	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4013	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4013	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
60429-287	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-287	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	Golden State Medical Supply	ANDA	Current
60429-288	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-288	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	Golden State Medical Supply	ANDA	Current
60429-289	Clomipramine Hydrochloride	Clomipramine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-289	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	Golden State Medical Supply	ANDA	Current
63629-4123	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
68084-790	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	American Health Packaging	ANDA	Current
68084-790	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	American Health Packaging	ANDA	Current
68084-790	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	American Health Packaging	ANDA	Current
68084-818	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	American Health Packaging	ANDA	Current
68084-818	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	American Health Packaging	ANDA	Current
68084-818	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	American Health Packaging	ANDA	Current
68151-3048	CLOMIPRAMINE HYDROCHLORIDE	Clomipramine Hydrochloride	Carilion Materials Management	ANDA	Current