Application 083799

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
002	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
003	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No

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

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	RLD / RS
A083799-001	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982
A083799-002	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982
A083799-003	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982

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 2 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083799-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083799-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083799-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083799-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083799-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083799-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A083799-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A083799-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083799-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083799-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083799-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083799-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A083799-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A083799-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083799-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A083799-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A083799-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083799-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083799-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083799-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083799-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A083799-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A083799-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083799-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A083799-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A083799-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083799-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083799-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083799-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083799-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A083799-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A083799-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083799-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A083799-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A083799-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083799-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A083799-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A083799-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083799-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A083799-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Leading Pharma, LLC	490263ce-b4d2-428a-87da-fcd07f85499a	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Imipramine Hydrochloride generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	830cb1cb-20a1-4617-a748-24241257a244	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Imipramine Hydrochloride generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	REMEDYREPACK INC.	02c19a0a-3d9d-4881-ad14-1687aafd87b5	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Imipramine Hydrochloride generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Strides Pharma Science Limited	51d3b181-0d15-4782-a966-feb137972b18	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Imipramine Hydrochloride generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	A-S Medication Solutions	d9dbcebe-9aba-4a93-a7b7-48d29e07d3c4	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Imipramine Hydrochloride generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Bryant Ranch Prepack	bcd3b62a-88d4-49eb-b0aa-71e28cf40919	2026-03-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Imipramine Hydrochloride generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Oxford Pharmaceuticals, LLC	a5f60cf1-6f14-40a3-a794-9d69b28088d8	2026-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Imipramine Hydrochloride generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Coupler LLC	48e8b819-a9a0-aa5a-e063-6394a90ad9c2	2026-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Imipramine Hydrochloride generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Proficient Rx LP	5997822f-ce83-4091-be71-21a6b01caaba	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Imipramine Hydrochloride generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Bryant Ranch Prepack	20af582f-08ba-4281-a2df-0bcf68c58594	2025-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Imipramine Hydrochloride generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine hydrochloride	IMIPRAMINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f887062a-7c82-664f-e053-6294a90a2773	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Imipramine hydrochloride generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	fd78fb8e-99ae-91b0-e053-6394a90a9271	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Imipramine Hydrochloride generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Key Therapeutics	9c685c94-64cd-442a-ade7-193c62d7a058	2024-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Imipramine Hydrochloride generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	209cc339-658a-577a-e063-6394a90a2b47	2024-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Imipramine Hydrochloride generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	55311747-710c-43c4-821d-76323ff2520e	2023-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Imipramine Hydrochloride generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Proficient Rx LP	3f90b8dd-7234-4428-b896-943d052dd05f	2023-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Imipramine Hydrochloride generic name: IMIPRAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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