Application 211818

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

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 42.

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
A211818-001	DROXIDOPA	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18
A211818-002	DROXIDOPA	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18
A211818-003	DROXIDOPA	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211818-001	AB
A211818-002	AB
A211818-003	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 · 105 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
2026-08-18 06:07:40	2026-07	A211818-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211818-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211818-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211818-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211818-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211818-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211818-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211818-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211818-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211818-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211818-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211818-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211818-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211818-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211818-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211818-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211818-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211818-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211818-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211818-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211818-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211818-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211818-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211818-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211818-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211818-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211818-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211818-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211818-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211818-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211818-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211818-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211818-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211818-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211818-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211818-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211818-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211818-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211818-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211818-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211818-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211818-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211818-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211818-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211818-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211818-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211818-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211818-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211818-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211818-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211818-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211818-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211818-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211818-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211818-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211818-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211818-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211818-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211818-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211818-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211818-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211818-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211818-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211818-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211818-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211818-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211818-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211818-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211818-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211818-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211818-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211818-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211818-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211818-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211818-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211818-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211818-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211818-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211818-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211818-001	AB	1	`1e350fbaab3a…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Droxidopa	DROXIDOPA	Zydus Lifesciences Limited	e9894e44-99ff-471a-bcc2-bfecd55a6559	2024-11-28		Exact identifier application applno (ANDA): 211818 application number: ANDA211818 ndc (product): 70771-1611 ndc (product): 70771-1610 ndc (product): 70771-1609
Droxidopa	DROXIDOPA	Zydus Pharmaceuticals USA Inc.	aa3ce55a-1ea9-4b50-b682-6f25398bcc29	2023-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211818 application number: ANDA211818 ndc (product): 70710-1389 ndc (product): 70710-1390 ndc (product): 70710-1391

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70710-1389	Droxidopa	Droxidopa	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1390	Droxidopa	Droxidopa	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1391	Droxidopa	Droxidopa	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1609	Droxidopa	Droxidopa	Zydus Lifesciences Limited	ANDA	Current
70771-1609	Droxidopa	Droxidopa	Cadila Healthcare Limited	ANDA	Current
70771-1610	Droxidopa	Droxidopa	Zydus Lifesciences Limited	ANDA	Current
70771-1610	Droxidopa	Droxidopa	Cadila Healthcare Limited	ANDA	Current
70771-1611	Droxidopa	Droxidopa	Zydus Lifesciences Limited	ANDA	Current
70771-1611	Droxidopa	Droxidopa	Cadila Healthcare Limited	ANDA	Current