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 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	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 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	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018013-001	PAMELOR	EQ 10MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018013-002	PAMELOR	EQ 25MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018013-003	PAMELOR	EQ 75MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018013-004	PAMELOR	EQ 50MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018013-001	PAMELOR	EQ 10MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018013-002	PAMELOR	EQ 25MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018013-003	PAMELOR	EQ 75MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018013-004	PAMELOR	EQ 50MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018013-001	PAMELOR	EQ 10MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018013-002	PAMELOR	EQ 25MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018013-003	PAMELOR	EQ 75MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018013-004	PAMELOR	EQ 50MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018013-001	PAMELOR	EQ 10MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018013-002	PAMELOR	EQ 25MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018013-003	PAMELOR	EQ 75MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018013-004	PAMELOR	EQ 50MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018013-001	PAMELOR	EQ 10MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018013-002	PAMELOR	EQ 25MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018013-003	PAMELOR	EQ 75MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018013-004	PAMELOR	EQ 50MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018013-001	PAMELOR	EQ 10MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018013-002	PAMELOR	EQ 25MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018013-003	PAMELOR	EQ 75MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018013-004	PAMELOR	EQ 50MG BASE	CAPSULE / ORAL		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018013-001	PAMELOR	EQ 10MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018013-002	PAMELOR	EQ 25MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018013-003	PAMELOR	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018013-004	PAMELOR	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018013-001	PAMELOR	EQ 10MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018013-002	PAMELOR	EQ 25MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018013-003	PAMELOR	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018013-004	PAMELOR	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018013-001	PAMELOR	EQ 10MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018013-002	PAMELOR	EQ 25MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018013-003	PAMELOR	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018013-004	PAMELOR	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018013-001	PAMELOR	EQ 10MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018013-002	PAMELOR	EQ 25MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018013-003	PAMELOR	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018013-004	PAMELOR	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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