Application 214869

Type: NDA
Sponsor: RIVERSIDE PHARMA CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DHIVY	CARBIDOPA;LEVODOPA	TABLET;ORAL	25MG;100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N214869-001	DHIVY	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET / ORAL		RLD, RS	2021-11-12

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214869-001	11033521	2039-03-28	U-219	Drug product	2022-02-22
N214869-001	11033521	2039-03-28	U-3304	Drug product	2022-02-22
N214869-001	11033521	2039-03-28	U-3305	Drug product	2022-02-22
N214869-001	11439613	2039-03-28	U-3557		2023-04-18
N214869-001	11819485	2039-03-28	U-3557		2023-12-07

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 137 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214869-001	11033521	2039-03-28	U-219	Drug product	2022-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214869-001	11033521	2039-03-28	U-3304	Drug product	2022-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214869-001	11033521	2039-03-28	U-3305	Drug product	2022-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214869-001	11439613	2039-03-28	U-3557		2023-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214869-001	11819485	2039-03-28	U-3557		2023-12-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214869-001	11033521	2039-03-28	U-219	Drug product	2022-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214869-001	11033521	2039-03-28	U-3304	Drug product	2022-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214869-001	11033521	2039-03-28	U-3305	Drug product	2022-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214869-001	11439613	2039-03-28	U-3557		2023-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214869-001	11819485	2039-03-28	U-3557		2023-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214869-001	11033521	2039-03-28	U-219	Drug product	2022-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214869-001	11033521	2039-03-28	U-3304	Drug product	2022-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214869-001	11033521	2039-03-28	U-3305	Drug product	2022-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214869-001	11439613	2039-03-28	U-3557		2023-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214869-001	11819485	2039-03-28	U-3557		2023-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214869-001	11033521	2039-03-28	U-219	Drug product	2022-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214869-001	11033521	2039-03-28	U-3304	Drug product	2022-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214869-001	11033521	2039-03-28	U-3305	Drug product	2022-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214869-001	11439613	2039-03-28	U-3557		2023-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214869-001	11819485	2039-03-28	U-3557		2023-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214869-001	11033521	2039-03-28	U-219	Drug product	2022-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214869-001	11033521	2039-03-28	U-3304	Drug product	2022-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214869-001	11033521	2039-03-28	U-3305	Drug product	2022-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214869-001	11439613	2039-03-28	U-3557		2023-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214869-001	11819485	2039-03-28	U-3557		2023-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214869-001	11033521	2039-03-28	U-219	Drug product	2022-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214869-001	11033521	2039-03-28	U-3304	Drug product	2022-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214869-001	11033521	2039-03-28	U-3305	Drug product	2022-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214869-001	11439613	2039-03-28	U-3557		2023-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214869-001	11819485	2039-03-28	U-3557		2023-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214869-001	11033521	2039-03-28	U-219	Drug product	2022-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214869-001	11033521	2039-03-28	U-3304	Drug product	2022-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214869-001	11033521	2039-03-28	U-3305	Drug product	2022-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214869-001	11439613	2039-03-28	U-3557		2023-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214869-001	11819485	2039-03-28	U-3557		2023-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214869-001	11033521	2039-03-28	U-219	Drug product	2022-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214869-001	11033521	2039-03-28	U-3304	Drug product	2022-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214869-001	11033521	2039-03-28	U-3305	Drug product	2022-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214869-001	11439613	2039-03-28	U-3557		2023-04-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214869-001	11819485	2039-03-28	U-3557		2023-12-07	`2680178bc6a6…`

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
Dhivy	CARBIDOPA LEVODOPA	Avion Pharmaceuticals, LLC	39d79ade-8ee0-40ba-9fdd-13045b8ddbdf	2026-08-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214869 application number: NDA214869 ndc (product): 75854-701

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
75854-701	Dhivy	Carbidopa Levodopa	Avion Pharmaceuticals, LLC	NDA	Current
75854-701	Dhivy	Carbidopa Levodopa	Avion Pharmaceuticals, LLC	NDA	Current
75854-701	Dhivy	Carbidopa Levodopa	Avion Pharmaceuticals, LLC	NDA	Current
75854-701	Dhivy	Carbidopa Levodopa	Avion Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85495	SUPPL	2026-03-24
85451	SUPPL	2026-03-23
71697	SUPPL	2022-08-02
71663	SUPPL	2022-07-29
71507	SUPPL	2022-07-05
71504	SUPPL	2022-07-01
71164	ORIG	2022-05-31
69317	ORIG	2021-11-16
69310	ORIG	2021-11-15