Application 214543

Type: ANDA
Sponsor: BLUEPHARMA

Application Products#

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

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	Approval date
A214543-001	DROXIDOPA	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-05-05
A214543-002	DROXIDOPA	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-05-05
A214543-003	DROXIDOPA	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-05-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214543-001	AB
A214543-002	AB
A214543-003	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 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214543-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214543-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214543-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-05-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214543-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214543-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214543-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-05-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214543-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214543-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214543-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-05-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214543-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214543-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214543-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-05-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214543-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214543-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214543-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-05-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214543-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214543-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214543-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-05-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214543-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-05-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214543-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-05-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214543-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-05-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214543-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-05-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214543-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-05-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214543-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214543-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-05-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214543-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-05-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214543-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214543-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-05-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214543-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-05-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214543-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214543-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-05-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214543-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-05-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214543-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214543-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-05-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214543-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-05-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214543-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-05-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214543-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-05-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214543-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-05-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214543-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-05-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214543-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-05-05	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 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	A214543-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214543-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214543-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214543-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214543-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214543-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214543-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214543-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214543-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214543-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214543-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214543-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214543-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214543-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214543-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214543-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214543-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214543-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214543-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214543-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214543-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214543-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214543-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214543-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214543-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214543-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214543-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214543-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214543-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214543-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214543-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214543-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214543-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214543-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214543-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214543-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214543-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214543-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214543-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214543-001	AB	1	`8072bd15b7f6…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Droxidopa	DROXIDOPA	Novadoz Pharmaceuticals LLC	381ffe44-d5d8-4380-a3cd-6d6a5e9ef55d	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Droxidopa generic name: DROXIDOPA
Droxidopa	DROXIDOPA	Ascend Laboratories, LLC	6091958e-f04e-47c0-9eef-9c204df4edd9	2025-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Droxidopa generic name: DROXIDOPA
Droxidopa	DROXIDOPA	CivicaScript LLC	f6dce609-c7d7-48a3-83bb-32ecf00f973f	2025-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Droxidopa generic name: DROXIDOPA
Droxidopa	DROXIDOPA	Zydus Lifesciences Limited	e9894e44-99ff-471a-bcc2-bfecd55a6559	2024-11-28		Name fallback brand name: Droxidopa generic name: DROXIDOPA
Droxidopa	DROXIDOPA	MAJOR PHARMACEUTICALS	04b1f69d-ebba-43b9-8ecd-4f6be7c8a0a0	2024-01-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Droxidopa generic name: DROXIDOPA
DROXIDOPA	DROXIDOPA	Lupin Pharmaceuticals, Inc.	81b798dc-b8dc-48a5-af46-82bb55f789a8	2023-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DROXIDOPA generic name: DROXIDOPA
Droxidopa	DROXIDOPA	Zydus Pharmaceuticals USA Inc.	aa3ce55a-1ea9-4b50-b682-6f25398bcc29	2023-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Droxidopa generic name: DROXIDOPA
Droxidopa	DROXIDOPA	Golden State Medical Supply, Inc.	fe08aebb-b390-d176-e053-6394a90a6be7	2023-06-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Droxidopa generic name: DROXIDOPA
droxidopa	DROXIDOPA	Slate Run Pharmaceuticals, LLC	049f997b-1649-467e-bbb9-bdb991b0bc6e	2023-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: droxidopa generic name: DROXIDOPA
Droxidopa	DROXIDOPA	Camber Pharmaceuticals, Inc.	c21ea27c-6e3b-4296-a118-c0b878cdf8f8	2021-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Droxidopa generic name: DROXIDOPA
DROXIDOPA	DROXIDOPA	Bionpharma Inc.	c3cfd280-3548-b590-e053-2a95a90a5eb3	2021-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DROXIDOPA generic name: DROXIDOPA
Droxidopa	DROXIDOPA	Aurobindo Pharma Limited	ff263c9a-3db2-45ac-9ba6-8fca47199604	2021-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Droxidopa generic name: DROXIDOPA
Droxidopa	DROXIDOPA	ScieGen Pharmaceuticals Inc	10b02d98-ebb8-4152-bd56-3402417fbf79	2021-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Droxidopa generic name: DROXIDOPA
droxidopa	DROXIDOPA	Sun Pharmaceutical Industries, Inc.	51ef3096-4622-4f45-a180-ab0dc6d46df9	2021-02-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: droxidopa generic name: DROXIDOPA
Northera	DROXIDOPA	Lundbeck Pharmaceuticals LLC	2179f02c-48d7-48eb-8007-5ae43d8d16bc	2019-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DROXIDOPA

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27808-199	droxidopa	droxidopa	Tris Pharma Inc	ANDA	Current
27808-199	droxidopa	droxidopa	Tris Pharma Inc	ANDA	Current
27808-200	droxidopa	droxidopa	Tris Pharma Inc	ANDA	Current
27808-200	droxidopa	droxidopa	Tris Pharma Inc	ANDA	Current
27808-201	droxidopa	droxidopa	Tris Pharma Inc	ANDA	Current
27808-201	droxidopa	droxidopa	Tris Pharma Inc	ANDA	Current