Application 213911

Type: ANDA
Sponsor: ALKEM LABS LTD

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
A213911-001	DROXIDOPA	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18
A213911-002	DROXIDOPA	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18
A213911-003	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
A213911-001	AB
A213911-002	AB
A213911-003	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 · 102 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	A213911-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213911-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213911-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213911-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213911-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213911-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213911-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213911-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213911-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213911-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213911-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213911-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213911-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213911-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213911-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213911-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213911-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213911-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213911-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213911-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213911-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213911-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213911-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213911-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213911-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213911-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213911-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213911-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213911-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213911-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213911-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213911-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213911-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213911-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213911-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213911-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213911-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213911-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213911-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213911-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A213911-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213911-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213911-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213911-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213911-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213911-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213911-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213911-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213911-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213911-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213911-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213911-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213911-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213911-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213911-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213911-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213911-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213911-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213911-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213911-003	AB	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213911-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213911-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213911-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213911-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213911-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213911-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213911-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213911-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213911-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213911-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213911-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213911-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213911-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213911-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213911-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213911-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213911-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213911-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213911-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213911-002	AB	1	`3f0d92c62455…`

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	Ascend Laboratories, LLC	6091958e-f04e-47c0-9eef-9c204df4edd9	2025-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213911 application number: ANDA213911 ndc (product): 67877-704 ndc (product): 67877-705 ndc (product): 67877-706
Droxidopa	DROXIDOPA	CivicaScript LLC	f6dce609-c7d7-48a3-83bb-32ecf00f973f	2025-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213911 application number: ANDA213911

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
67877-704	Droxidopa	Droxidopa	Ascend Laboratories, LLC	ANDA	Current
67877-704	Droxidopa	Droxidopa	Ascend Laboratories, LLC	ANDA	Current
67877-705	Droxidopa	Droxidopa	Ascend Laboratories, LLC	ANDA	Current
67877-705	Droxidopa	Droxidopa	Ascend Laboratories, LLC	ANDA	Current
67877-706	Droxidopa	Droxidopa	Ascend Laboratories, LLC	ANDA	Current
67877-706	Droxidopa	Droxidopa	Ascend Laboratories, LLC	ANDA	Current