Application 090444

Type: ANDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMIPRAMINE PAMOATE	IMIPRAMINE PAMOATE	CAPSULE;ORAL	EQ 75MG HYDROCHLORIDE	No	No
002	IMIPRAMINE PAMOATE	IMIPRAMINE PAMOATE	CAPSULE;ORAL	EQ 100MG HYDROCHLORIDE	No	No
003	IMIPRAMINE PAMOATE	IMIPRAMINE PAMOATE	CAPSULE;ORAL	EQ 125MG HYDROCHLORIDE	No	No
004	IMIPRAMINE PAMOATE	IMIPRAMINE PAMOATE	CAPSULE;ORAL	EQ 150MG HYDROCHLORIDE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090444-001	IMIPRAMINE PAMOATE	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16
A090444-002	IMIPRAMINE PAMOATE	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16
A090444-003	IMIPRAMINE PAMOATE	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16
A090444-004	IMIPRAMINE PAMOATE	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090444-001	AB
A090444-002	AB
A090444-003	AB
A090444-004	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 5 · 172 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
2026-09-14 22:38:34	2026-08	A090444-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090444-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090444-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090444-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090444-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090444-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090444-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090444-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090444-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090444-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090444-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090444-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090444-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090444-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090444-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090444-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090444-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090444-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090444-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090444-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090444-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090444-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090444-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090444-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090444-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090444-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090444-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090444-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090444-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090444-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090444-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090444-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090444-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090444-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090444-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090444-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090444-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090444-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090444-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090444-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090444-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090444-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090444-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090444-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090444-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090444-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090444-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090444-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090444-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090444-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090444-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090444-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090444-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090444-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090444-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090444-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090444-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090444-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090444-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090444-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090444-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090444-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090444-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090444-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090444-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090444-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090444-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090444-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090444-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090444-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090444-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090444-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090444-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090444-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090444-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090444-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090444-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090444-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090444-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090444-004	AB	1	`5bbf6a4d5a75…`

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
Imipramine Pamoate	IMIPRAMINE PAMOATE	REMEDYREPACK INC.	76f412fd-f476-40c6-8aa7-9abced75c3e8	2026-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090444 application number: ANDA090444
Imipramine Pamoate	IMIPRAMINE PAMOATE	Lupin Pharmaceuticals, Inc.	d1dde497-1889-4424-af18-da7ca6459cf3	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090444 application number: ANDA090444 ndc (product): 68180-317 ndc (product): 68180-314 ndc (product): 68180-315 ndc (product): 68180-316

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57297-314	Imipramine Pamoate	Imipramine Pamoate	LUPIN LIMITED	ANDA	Current
57297-315	Imipramine Pamoate	Imipramine Pamoate	LUPIN LIMITED	ANDA	Current
57297-316	Imipramine Pamoate	Imipramine Pamoate	LUPIN LIMITED	ANDA	Current
57297-317	Imipramine Pamoate	Imipramine Pamoate	LUPIN LIMITED	ANDA	Current
68180-314	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-314	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-314	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-314	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-314	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-314	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-315	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-315	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-315	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-315	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-315	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-315	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-316	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-316	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-316	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-316	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-316	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-316	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-317	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-317	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-317	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-317	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-317	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-317	Imipramine Pamoate	Imipramine Pamoate	Lupin Pharmaceuticals, Inc.	ANDA	Current