Application 203202

Type: NDA
Sponsor: LUNDBECK NA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NORTHERA	DROXIDOPA	CAPSULE;ORAL	100MG	Yes	No
002	NORTHERA	DROXIDOPA	CAPSULE;ORAL	200MG	Yes	No
003	NORTHERA	DROXIDOPA	CAPSULE;ORAL	300MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203202-001	NORTHERA	DROXIDOPA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18
N203202-002	NORTHERA	DROXIDOPA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18
N203202-003	NORTHERA	DROXIDOPA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N203202-001	AB
N203202-002	AB
N203202-003	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 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	N203202-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203202-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203202-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203202-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203202-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203202-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203202-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203202-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203202-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203202-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203202-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203202-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203202-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203202-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203202-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203202-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203202-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203202-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203202-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203202-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203202-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203202-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203202-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203202-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203202-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203202-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203202-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203202-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203202-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203202-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203202-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203202-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203202-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203202-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203202-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203202-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203202-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203202-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203202-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203202-001	AB	1	`8072bd15b7f6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N203202-001	NCE	2019-02-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203202-001	ODE-61	2021-02-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203202-002	NCE	2019-02-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203202-002	ODE-61	2021-02-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203202-003	NCE	2019-02-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203202-003	ODE-61	2021-02-18	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N203202-001	ODE-61	2021-02-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203202-002	ODE-61	2021-02-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203202-003	ODE-61	2021-02-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203202-001	ODE-61	2021-02-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203202-002	ODE-61	2021-02-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203202-003	ODE-61	2021-02-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203202-001	ODE-61	2021-02-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N203202-002	ODE-61	2021-02-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N203202-003	ODE-61	2021-02-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203202-001	ODE-61	2021-02-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203202-002	ODE-61	2021-02-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203202-003	ODE-61	2021-02-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203202-001	ODE-61	2021-02-18	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N203202-002	ODE-61	2021-02-18	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N203202-003	ODE-61	2021-02-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203202-001	NCE	2019-02-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203202-001	ODE-61	2021-02-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203202-002	NCE	2019-02-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203202-002	ODE-61	2021-02-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203202-003	NCE	2019-02-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203202-003	ODE-61	2021-02-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203202-001	NCE	2019-02-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203202-001	ODE-61	2021-02-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203202-002	NCE	2019-02-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203202-002	ODE-61	2021-02-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203202-003	NCE	2019-02-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203202-003	ODE-61	2021-02-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203202-001	NCE	2019-02-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203202-001	ODE-61	2021-02-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203202-002	NCE	2019-02-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203202-002	ODE-61	2021-02-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203202-003	NCE	2019-02-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203202-003	ODE-61	2021-02-18	`ea99ee380514…`

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
Northera	DROXIDOPA	Lundbeck Pharmaceuticals LLC	2179f02c-48d7-48eb-8007-5ae43d8d16bc	2019-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203202 application number: NDA203202 ndc (product): 67386-822 ndc (product): 67386-820 ndc (product): 67386-821

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67386-820	Northera	droxidopa	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-820	Northera	droxidopa	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-820	Northera	droxidopa	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-820	Northera	droxidopa	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-820	Northera	droxidopa	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-820	Northera	droxidopa	Lundbeck Pharmaceuticals	NDA	Current
67386-821	Northera	droxidopa	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-821	Northera	droxidopa	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-821	Northera	droxidopa	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-821	Northera	droxidopa	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-821	Northera	droxidopa	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-821	Northera	droxidopa	Lundbeck Pharmaceuticals	NDA	Current
67386-822	Northera	droxidopa	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-822	Northera	droxidopa	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-822	Northera	droxidopa	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-822	Northera	droxidopa	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-822	Northera	droxidopa	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-822	Northera	droxidopa	Lundbeck Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47177	SUPPL	2017-02-13
47175	SUPPL	2017-02-13
45493	SUPPL	2016-10-06
45477	SUPPL	2016-10-05
22915	ORIG	2014-03-20
40274	ORIG	2014-02-19
10183	ORIG	2014-02-19