Application 018013

Type: NDA
Sponsor: SPECGX LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PAMELOR	NORTRIPTYLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE	Yes	No
002	PAMELOR	NORTRIPTYLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 25MG BASE	Yes	No
003	PAMELOR	NORTRIPTYLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 75MG BASE	Yes	Yes
004	PAMELOR	NORTRIPTYLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 50MG BASE	Yes	No

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

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	RLD / RS
N018013-001	PAMELOR	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	RLD, Approved before 1982
N018013-002	PAMELOR	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	RLD, Approved before 1982
N018013-003	PAMELOR	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	RLD, Approved before 1982
N018013-004	PAMELOR	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	RLD, 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 5 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N018013-001	PAMELOR	EQ 10MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N018013-002	PAMELOR	EQ 25MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N018013-003	PAMELOR	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N018013-004	PAMELOR	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018013-001	PAMELOR	EQ 10MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N018013-002	PAMELOR	EQ 25MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N018013-003	PAMELOR	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N018013-004	PAMELOR	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018013-001	PAMELOR	EQ 10MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018013-002	PAMELOR	EQ 25MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018013-003	PAMELOR	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018013-004	PAMELOR	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018013-001	PAMELOR	EQ 10MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018013-002	PAMELOR	EQ 25MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018013-003	PAMELOR	EQ 75MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018013-004	PAMELOR	EQ 50MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018013-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018013-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018013-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018013-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018013-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018013-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018013-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018013-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018013-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018013-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018013-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018013-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018013-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018013-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018013-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018013-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018013-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018013-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018013-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018013-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018013-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018013-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018013-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018013-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018013-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018013-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018013-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018013-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018013-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018013-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018013-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018013-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018013-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018013-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018013-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018013-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018013-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018013-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018013-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018013-004	AB	1	`5d02ea3f76ae…`

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
PAMELOR	NORTRIPTYLINE HYDROCHLORIDE	SpecGx LLC	e17dc299-f52d-414d-ab6e-e809bd6f8acb	2024-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018013 application number: NDA018013 ndc (product): 0406-9912 ndc (product): 0406-9913 ndc (product): 0406-9910 ndc (product): 0406-9911

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0406-9910	PAMELOR	nortriptyline hydrochloride	SpecGx LLC	NDA	Current
0406-9910	PAMELOR	nortriptyline hydrochloride	SpecGx LLC	NDA	Current
0406-9910	PAMELOR	nortriptyline hydrochloride	SpecGx LLC	NDA	Current
0406-9911	PAMELOR	nortriptyline hydrochloride	SpecGx LLC	NDA	Current
0406-9911	PAMELOR	nortriptyline hydrochloride	SpecGx LLC	NDA	Current
0406-9911	PAMELOR	nortriptyline hydrochloride	SpecGx LLC	NDA	Current
0406-9912	PAMELOR	nortriptyline hydrochloride	SpecGx LLC	NDA	Current
0406-9912	PAMELOR	nortriptyline hydrochloride	SpecGx LLC	NDA	Current
0406-9912	PAMELOR	nortriptyline hydrochloride	SpecGx LLC	NDA	Current
0406-9913	PAMELOR	nortriptyline hydrochloride	SpecGx LLC	NDA	Current
0406-9913	PAMELOR	nortriptyline hydrochloride	SpecGx LLC	NDA	Current
0406-9913	PAMELOR	nortriptyline hydrochloride	SpecGx LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58276	SUPPL	2019-04-10
58270	SUPPL	2019-04-10
58269	SUPPL	2019-04-10
11115	SUPPL	2014-07-29
779	SUPPL	2014-07-29
13979	SUPPL	2014-07-11
11114	SUPPL	2014-07-11
13978	SUPPL	2012-10-29
33393	SUPPL	2012-10-26
23111	ORIG	2009-11-20
20101	SUPPL	2009-09-14
778	SUPPL	2007-07-24
33392	SUPPL	2007-07-16
23539	ORIG	2007-05-09
13977	SUPPL	2005-01-13
11113	SUPPL	2005-01-13