Application 204963

Type: ANDA
Sponsor: NOVAST LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
002	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
003	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
004	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	TABLET;ORAL	75MG	No	No
005	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
006	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	TABLET;ORAL	150MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204963-001	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-12-26
A204963-002	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-12-26
A204963-003	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-12-26
A204963-004	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-12-26
A204963-005	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-26
A204963-006	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-12-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A204963-001	AB
A204963-002	AB
A204963-003	AB
A204963-004	AB
A204963-005	AB
A204963-006	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 7 · 246 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
2026-02-19 14:30 UTC	2026-02	A204963-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204963-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204963-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204963-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204963-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204963-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204963-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204963-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204963-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204963-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204963-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204963-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204963-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204963-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204963-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204963-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-12-26	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 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	A204963-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204963-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204963-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204963-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204963-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204963-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204963-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204963-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204963-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204963-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204963-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204963-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204963-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204963-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204963-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204963-004	AB	1	`2680178bc6a6…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	REMEDYREPACK INC.	dc1601be-e16a-411f-b9b8-01c51abb2441	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204963 application number: ANDA204963
DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Ingenus Pharmaceuticals, LLC	7280f157-3fff-41c5-b3f4-510b8bacdaba	2025-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204963 application number: ANDA204963 ndc (product): 50742-113 ndc (product): 50742-116 ndc (product): 50742-115 ndc (product): 50742-114 ndc (product): 50742-112 ndc (product): 50742-117
Desipramine HCL	DESIPRAMINE HCL	Direct_Rx	ed9d2290-9ad9-ecff-e053-2a95a90a5fd6	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204963 application number: ANDA204963 ndc (product): 72189-391

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50742-112	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-112	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-112	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-113	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-113	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-113	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-114	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-114	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-114	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-115	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-115	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-115	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-116	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-116	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-116	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-117	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-117	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-117	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
72189-391	Desipramine HCL	Desipramine HCL	Direct_Rx	ANDA	Current