Application 091099

Type: ANDA
Sponsor: HIKMA

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	Yes
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 1.

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	RLD / RS	Approval date
A091099-001	IMIPRAMINE PAMOATE	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2010-04-16
A091099-002	IMIPRAMINE PAMOATE	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2010-04-16
A091099-003	IMIPRAMINE PAMOATE	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2010-04-16
A091099-004	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
A091099-001	AB
A091099-002	AB
A091099-003	AB
A091099-004	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 · 164 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
2026-02-19 14:30 UTC	2026-02	A091099-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2010-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091099-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2010-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091099-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2010-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091099-004	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	A091099-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2010-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091099-002	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	A091099-003	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	A091099-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2010-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091099-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2010-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091099-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2010-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091099-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2010-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091099-004	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	A091099-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2010-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091099-002	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	A091099-003	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	A091099-004	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	A091099-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2010-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091099-002	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	A091099-003	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	A091099-004	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	A091099-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2010-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091099-002	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	A091099-003	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	A091099-004	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	A091099-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2010-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091099-002	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	A091099-003	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	A091099-004	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	A091099-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2010-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091099-002	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	A091099-003	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	A091099-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2010-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091099-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2010-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091099-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2010-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091099-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2010-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091099-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2010-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091099-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2010-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091099-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2010-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091099-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2010-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091099-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2010-04-16	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091099-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091099-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091099-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091099-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091099-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091099-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091099-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091099-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091099-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091099-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091099-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091099-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091099-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091099-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091099-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091099-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091099-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091099-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091099-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091099-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091099-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091099-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091099-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091099-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091099-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091099-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091099-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091099-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091099-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091099-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091099-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091099-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091099-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091099-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091099-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091099-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091099-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091099-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091099-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091099-004	AB	1	`d06236e962d9…`

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
Imipramine Pamoate	IMIPRAMINE PAMOATE	Hikma Pharmaceuticals USA Inc	6e780825-2a66-41fd-a04c-78fa7c4df05e	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091099 application number: ANDA091099 ndc (product): 0054-0276 ndc (product): 0054-0273 ndc (product): 0054-0274 ndc (product): 0054-0275

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0273	Imipramine Pamoate	Imipramine Pamoate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0273	Imipramine Pamoate	Imipramine Pamoate	Hikma Pharmaceuticals USA Inc	ANDA	Current
0054-0273	Imipramine Pamoate	Imipramine Pamoate	West-Ward Pharmaceuticals	ANDA	Current
0054-0274	Imipramine Pamoate	Imipramine Pamoate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0274	Imipramine Pamoate	Imipramine Pamoate	Hikma Pharmaceuticals USA Inc	ANDA	Current
0054-0274	Imipramine Pamoate	Imipramine Pamoate	West-Ward Pharmaceuticals	ANDA	Current
0054-0275	Imipramine Pamoate	Imipramine Pamoate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0275	Imipramine Pamoate	Imipramine Pamoate	Hikma Pharmaceuticals USA Inc	ANDA	Current
0054-0275	Imipramine Pamoate	Imipramine Pamoate	West-Ward Pharmaceuticals	ANDA	Current
0054-0276	Imipramine Pamoate	Imipramine Pamoate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0276	Imipramine Pamoate	Imipramine Pamoate	Hikma Pharmaceuticals USA Inc	ANDA	Current
0054-0276	Imipramine Pamoate	Imipramine Pamoate	West-Ward Pharmaceuticals	ANDA	Current