Application 213897

Type: ANDA
Sponsor: AJANTA PHARMA LTD

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	Approval date
A213897-001	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	2020-10-02
A213897-002	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	2020-10-02
A213897-003	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	2020-10-02

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 3 · 114 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	A213897-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL		2020-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213897-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL		2020-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213897-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL		2020-10-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213897-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL		2020-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213897-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL		2020-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213897-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL		2020-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213897-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL		2020-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213897-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL		2020-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213897-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL		2020-10-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213897-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL		2020-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213897-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL		2020-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213897-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL		2020-10-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213897-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL		2020-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213897-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL		2020-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213897-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL		2020-10-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213897-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL		2020-10-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213897-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL		2020-10-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213897-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL		2020-10-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213897-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL		2020-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213897-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL		2020-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213897-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL		2020-10-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213897-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213897-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213897-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-10-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213897-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-10-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213897-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-10-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213897-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-10-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213897-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-10-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213897-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-10-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213897-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-10-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213897-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-10-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213897-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-10-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213897-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-10-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213897-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-10-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213897-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-10-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213897-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-10-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213897-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-10-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213897-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-10-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213897-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-10-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213897-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-10-02	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213897-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213897-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213897-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213897-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213897-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213897-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213897-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213897-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213897-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213897-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213897-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213897-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213897-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213897-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213897-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213897-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213897-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213897-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213897-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213897-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213897-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213897-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213897-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213897-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213897-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213897-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213897-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213897-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213897-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213897-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213897-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213897-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213897-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213897-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213897-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213897-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213897-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213897-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213897-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213897-001	AB	1	`87673890dc5c…`

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	Ajanta Pharma USA Inc.	0bf3c4f3-cf70-490d-89d8-9fb84962489e	2021-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213897 application number: ANDA213897 ndc (product): 27241-210 ndc (product): 27241-212 ndc (product): 27241-211

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27241-210	Clomipramine hydrochloride	Clomipramine hydrochloride	Ajanta Pharma Limited	ANDA	Current
27241-210	Clomipramine hydrochloride	Clomipramine hydrochloride	Ajanta Pharma USA Inc.	ANDA	Current
27241-211	Clomipramine hydrochloride	Clomipramine hydrochloride	Ajanta Pharma Limited	ANDA	Current
27241-211	Clomipramine hydrochloride	Clomipramine hydrochloride	Ajanta Pharma USA Inc.	ANDA	Current
27241-212	Clomipramine hydrochloride	Clomipramine hydrochloride	Ajanta Pharma Limited	ANDA	Current
27241-212	Clomipramine hydrochloride	Clomipramine hydrochloride	Ajanta Pharma USA Inc.	ANDA	Current