Application 014399

Type: NDA
Sponsor: US PHARM HOLDINGS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS	Approval date
N014399-001	NORPRAMIN	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	RLD, Approved before 1982
N014399-003	NORPRAMIN	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	RLD, Approved before 1982
N014399-004	NORPRAMIN	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	RLD, Approved before 1982
N014399-005	NORPRAMIN	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	RLD, Approved before 1982
N014399-006	NORPRAMIN	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	RLD, Approved before 1982
N014399-007	NORPRAMIN	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	RLD	1982-02-11

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 4 of 7 · 264 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
2019-12-13 00:20 UTC	2019-12	N014399-001	NORPRAMIN	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N014399-003	NORPRAMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N014399-004	NORPRAMIN	75MG	TABLET / ORAL	AB	RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N014399-005	NORPRAMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N014399-006	NORPRAMIN	150MG	TABLET / ORAL	AB	RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N014399-007	NORPRAMIN	10MG	TABLET / ORAL	AB	RLD	1982-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N014399-001	NORPRAMIN	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N014399-003	NORPRAMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N014399-004	NORPRAMIN	75MG	TABLET / ORAL	AB	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N014399-005	NORPRAMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N014399-006	NORPRAMIN	150MG	TABLET / ORAL	AB	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N014399-007	NORPRAMIN	10MG	TABLET / ORAL	AB	RLD	1982-02-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N014399-001	NORPRAMIN	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N014399-003	NORPRAMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N014399-004	NORPRAMIN	75MG	TABLET / ORAL	AB	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N014399-005	NORPRAMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N014399-006	NORPRAMIN	150MG	TABLET / ORAL	AB	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N014399-007	NORPRAMIN	10MG	TABLET / ORAL	AB	RLD	1982-02-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N014399-001	NORPRAMIN	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N014399-003	NORPRAMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N014399-004	NORPRAMIN	75MG	TABLET / ORAL	AB	RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N014399-005	NORPRAMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N014399-006	NORPRAMIN	150MG	TABLET / ORAL	AB	RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N014399-007	NORPRAMIN	10MG	TABLET / ORAL	AB	RLD	1982-02-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N014399-001	NORPRAMIN	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N014399-003	NORPRAMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N014399-004	NORPRAMIN	75MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N014399-005	NORPRAMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N014399-006	NORPRAMIN	150MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N014399-007	NORPRAMIN	10MG	TABLET / ORAL	AB	RLD	1982-02-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N014399-001	NORPRAMIN	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N014399-003	NORPRAMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N014399-004	NORPRAMIN	75MG	TABLET / ORAL	AB	RLD, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N014399-005	NORPRAMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N014399-006	NORPRAMIN	150MG	TABLET / ORAL	AB	RLD, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N014399-007	NORPRAMIN	10MG	TABLET / ORAL	AB	RLD	1982-02-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N014399-001	NORPRAMIN	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N014399-003	NORPRAMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N014399-004	NORPRAMIN	75MG	TABLET / ORAL	AB	RLD, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N014399-005	NORPRAMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`c0c555d07b60…`

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	N014399-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N014399-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N014399-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N014399-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N014399-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N014399-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N014399-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N014399-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N014399-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N014399-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N014399-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N014399-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N014399-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N014399-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N014399-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N014399-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N014399-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N014399-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N014399-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N014399-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N014399-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N014399-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N014399-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N014399-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N014399-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N014399-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N014399-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N014399-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N014399-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N014399-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N014399-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N014399-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N014399-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N014399-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N014399-006	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N014399-007	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N014399-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N014399-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N014399-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N014399-005	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Norpramin	DESIPRAMINE HYDROCHLORIDE	Validus Pharmaceuticals LLC	70b562ea-9f21-4e4a-b3ed-0590b2892f6a	2025-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 014399 application number: NDA014399 ndc (product): 30698-021 ndc (product): 30698-015 ndc (product): 30698-007 ndc (product): 30698-011 ndc (product): 30698-019 ndc (product): 30698-020

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0068-0007	Norpramin	desipramine hydrochloride	sanofi-aventis U.S. LLC	NDA	Current
0955-1030	Desipramine Hydrochloride	desipramine hydrochloride	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
30698-007	Norpramin	desipramine hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-007	Norpramin	desipramine hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-011	Norpramin	desipramine hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-011	Norpramin	desipramine hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-015	Norpramin	desipramine hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-015	Norpramin	desipramine hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-019	Norpramin	desipramine hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-019	Norpramin	desipramine hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-020	Norpramin	desipramine hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-020	Norpramin	desipramine hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-021	Norpramin	desipramine hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-021	Norpramin	desipramine hydrochloride	Validus Pharmaceuticals LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82715	SUPPL	2025-06-30
82661	SUPPL	2025-06-25
56444	SUPPL	2018-11-15
56418	SUPPL	2018-11-13
10843	SUPPL	2014-07-03
377	SUPPL	2014-07-03
33121	SUPPL	2012-11-26
33120	SUPPL	2012-11-26
23096	SUPPL	2012-11-26
12065	SUPPL	2012-11-21
376	SUPPL	2012-11-21
12064	SUPPL	2009-11-19
10842	SUPPL	2009-10-30
33119	SUPPL	2007-07-31
12063	SUPPL	2007-07-31
44003	ORIG	2007-05-09
375	SUPPL	2006-04-13
10841	SUPPL	2006-04-12
33118	SUPPL	2005-01-13
374	SUPPL	2005-01-13