Application 019906

Type: NDA
Sponsor: SPECGX LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ANAFRANIL	CLOMIPRAMINE HYDROCHLORIDE	CAPSULE;ORAL	25MG	Yes	Yes
002	ANAFRANIL	CLOMIPRAMINE HYDROCHLORIDE	CAPSULE;ORAL	50MG	Yes	No
003	ANAFRANIL	CLOMIPRAMINE HYDROCHLORIDE	CAPSULE;ORAL	75MG	Yes	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	RLD / RS	Approval date
N019906-001	ANAFRANIL	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RLD, RS	1989-12-29
N019906-002	ANAFRANIL	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	RLD	1989-12-29
N019906-003	ANAFRANIL	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	RLD	1989-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019906-001	AB
N019906-002	AB
N019906-003	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019906-001	ANAFRANIL	25MG	CAPSULE / ORAL	AB	RLD, RS	1989-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019906-002	ANAFRANIL	50MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019906-003	ANAFRANIL	75MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019906-001	ANAFRANIL	25MG	CAPSULE / ORAL	AB	RLD, RS	1989-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019906-002	ANAFRANIL	50MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019906-003	ANAFRANIL	75MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019906-001	ANAFRANIL	25MG	CAPSULE / ORAL	AB	RLD, RS	1989-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019906-002	ANAFRANIL	50MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019906-003	ANAFRANIL	75MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019906-001	ANAFRANIL	25MG	CAPSULE / ORAL	AB	RLD, RS	1989-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019906-002	ANAFRANIL	50MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019906-003	ANAFRANIL	75MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019906-001	ANAFRANIL	25MG	CAPSULE / ORAL	AB	RLD, RS	1989-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019906-002	ANAFRANIL	50MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019906-003	ANAFRANIL	75MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019906-001	ANAFRANIL	25MG	CAPSULE / ORAL	AB	RLD, RS	1989-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019906-002	ANAFRANIL	50MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019906-003	ANAFRANIL	75MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019906-001	ANAFRANIL	25MG	CAPSULE / ORAL	AB	RLD, RS	1989-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019906-002	ANAFRANIL	50MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019906-003	ANAFRANIL	75MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019906-001	ANAFRANIL	25MG	CAPSULE / ORAL	AB	RLD, RS	1989-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019906-002	ANAFRANIL	50MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019906-003	ANAFRANIL	75MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019906-001	ANAFRANIL	25MG	CAPSULE / ORAL	AB	RLD, RS	1989-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019906-002	ANAFRANIL	50MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019906-003	ANAFRANIL	75MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019906-001	ANAFRANIL	25MG	CAPSULE / ORAL	AB	RLD, RS	1989-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019906-002	ANAFRANIL	50MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019906-003	ANAFRANIL	75MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019906-001	ANAFRANIL	25MG	CAPSULE / ORAL	AB	RLD, RS	1989-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019906-002	ANAFRANIL	50MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019906-003	ANAFRANIL	75MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019906-001	ANAFRANIL	25MG	CAPSULE / ORAL	AB	RLD, RS	1989-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019906-002	ANAFRANIL	50MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019906-003	ANAFRANIL	75MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019906-001	ANAFRANIL	25MG	CAPSULE / ORAL	AB	RLD, RS	1989-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019906-002	ANAFRANIL	50MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019906-003	ANAFRANIL	75MG	CAPSULE / ORAL	AB	RLD	1989-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019906-001	ANAFRANIL	25MG	CAPSULE / ORAL	AB	RLD, RS	1989-12-29	`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	N019906-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019906-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019906-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019906-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019906-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019906-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019906-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019906-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019906-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019906-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019906-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019906-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019906-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019906-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019906-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019906-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019906-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019906-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019906-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019906-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019906-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019906-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019906-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019906-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019906-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019906-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019906-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019906-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019906-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019906-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019906-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019906-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019906-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019906-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019906-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019906-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019906-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019906-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019906-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019906-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ANAFRANIL	CLOMIPRAMINE HYDROCHLORIDE	SpecGx LLC	4074b555-7635-41a9-809d-fae3b3610059	2024-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019906 application number: NDA019906 ndc (product): 0406-9907 ndc (product): 0406-9908 ndc (product): 0406-9906
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	SpecGx LLC	d7cee3fa-d05c-4702-8f75-f446627bdb49	2024-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019906 application number: NDA019906 ndc (product): 0406-8808 ndc (product): 0406-8807 ndc (product): 0406-8806

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0406-8806	CLOMIPRAMINE HYDROCHLORIDE	clomipramine hydrochloride	SpecGx LLC	NDA	Current
0406-8806	CLOMIPRAMINE HYDROCHLORIDE	clomipramine hydrochloride	SpecGx LLC	NDA	Current
0406-8807	CLOMIPRAMINE HYDROCHLORIDE	clomipramine hydrochloride	SpecGx LLC	NDA	Current
0406-8807	CLOMIPRAMINE HYDROCHLORIDE	clomipramine hydrochloride	SpecGx LLC	NDA	Current
0406-8808	CLOMIPRAMINE HYDROCHLORIDE	clomipramine hydrochloride	SpecGx LLC	NDA	Current
0406-8808	CLOMIPRAMINE HYDROCHLORIDE	clomipramine hydrochloride	SpecGx LLC	NDA	Current
0406-9906	ANAFRANIL	clomipramine hydrochloride	SpecGx LLC	NDA	Current
0406-9906	ANAFRANIL	clomipramine hydrochloride	SpecGx LLC	NDA	Current
0406-9906	ANAFRANIL	clomipramine hydrochloride	SpecGx LLC	NDA	Current
0406-9907	ANAFRANIL	clomipramine hydrochloride	SpecGx LLC	NDA	Current
0406-9907	ANAFRANIL	clomipramine hydrochloride	SpecGx LLC	NDA	Current
0406-9907	ANAFRANIL	clomipramine hydrochloride	SpecGx LLC	NDA	Current
0406-9908	ANAFRANIL	clomipramine hydrochloride	SpecGx LLC	NDA	Current
0406-9908	ANAFRANIL	clomipramine hydrochloride	SpecGx LLC	NDA	Current
0406-9908	ANAFRANIL	clomipramine hydrochloride	SpecGx LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58694	SUPPL	2019-05-14
58671	SUPPL	2019-05-14
58668	SUPPL	2019-05-14
55322	SUPPL	2018-08-27
48546	SUPPL	2017-05-26
48533	SUPPL	2017-05-25
19827	SUPPL	2014-07-29
11838	SUPPL	2014-07-29
11837	SUPPL	2014-07-11
1800	SUPPL	2014-07-11
1799	SUPPL	2012-10-29
11836	SUPPL	2012-10-26
19826	SUPPL	2007-07-24
11835	SUPPL	2007-07-16
41091	SUPPL	2007-06-12
23559	ORIG	2007-05-09
11834	SUPPL	2005-01-13
1798	SUPPL	2005-01-13
19825	SUPPL	2004-09-07
34087	SUPPL	2003-06-10