Application 018012

Type: NDA
Sponsor: SPECGX LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PAMELOR	NORTRIPTYLINE HYDROCHLORIDE	SOLUTION;ORAL	EQ 10MG BASE/5ML	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018012-001	PAMELOR	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / 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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`f41ea6bd6efb…`

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 3 of 3 · 55 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	51778813-0ec1-6b4f-e054-00144ff8d46c	2024-07-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	8a294b63-7268-4105-8e17-a59ef889d572	2024-07-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	1a904ddf-574a-8a24-e063-6394a90aba3b	2024-06-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	dbe85bdc-17a1-4201-bf48-a52e35d69b68	2024-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	4442f029-dd5e-4834-9b01-eb8c638ce4b1	2024-02-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	8811104b-6223-4ea6-a9c6-61d63a21b3cd	2024-02-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	53346b9c-40a1-4b5b-8df0-0b393661fb85	2024-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	f1868790-c70b-4979-974d-3ce0ffe99e36	2024-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	DIRECT RX	45884cad-4a2d-44f4-93bd-16b130daf32d	2024-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	b1d9582c-742c-91a8-c2b3-bbdb21220470	2023-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	30263e15-de21-4db4-aceb-59d619909e82	2023-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	70921f99-1f25-4a8c-8269-6d5d26be7a63	2023-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	59a65e6f-b812-4195-b85b-c412fb902c93	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	c5b1ef5e-9681-426a-abf6-60d9c28d92a0	2022-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Mayne Pharma Inc.	765d726b-fd4b-4ef7-afd7-9e7e9bf8cae6	2021-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
33391	SUPPL	2014-07-29
13976	SUPPL	2014-07-29
11112	SUPPL	2014-07-11
777	SUPPL	2014-07-11
776	SUPPL	2012-10-29
11111	SUPPL	2012-10-26
43603	ORIG	2009-11-20
40770	SUPPL	2009-09-14
775	SUPPL	2007-07-24
33390	SUPPL	2007-07-16
44016	ORIG	2007-05-09
11110	SUPPL	2005-01-13
774	SUPPL	2005-01-13
33389	SUPPL	2003-04-11