Application 213212

Type: ANDA
Sponsor: RISING

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA	TABLET;ORAL	12.5MG;200MG;50MG	No	No
002	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA	TABLET;ORAL	18.75MG;200MG;75MG	No	No
003	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA	TABLET;ORAL	25MG;200MG;100MG	No	No
004	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA	TABLET;ORAL	31.25MG;200MG;125MG	No	No
005	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA	TABLET;ORAL	37.5MG;200MG;150MG	No	No
006	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA	TABLET;ORAL	50MG;200MG;200MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A213212-001	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA	12.5MG;200MG;50MG	TABLET / ORAL	AB	2022-01-25
A213212-002	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA	18.75MG;200MG;75MG	TABLET / ORAL	AB	2022-01-25
A213212-003	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA	25MG;200MG;100MG	TABLET / ORAL	AB	2022-01-25
A213212-004	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA	31.25MG;200MG;125MG	TABLET / ORAL	AB	2022-01-25
A213212-005	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA	37.5MG;200MG;150MG	TABLET / ORAL	AB	2022-01-25
A213212-006	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA	50MG;200MG;200MG	TABLET / ORAL	AB	2022-01-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A213212-001	AB
A213212-002	AB
A213212-003	AB
A213212-004	AB
A213212-005	AB
A213212-006	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 5 · 192 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	A213212-001	CARBIDOPA, LEVODOPA AND ENTACAPONE	12.5MG;200MG;50MG	TABLET / ORAL	AB	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213212-002	CARBIDOPA, LEVODOPA AND ENTACAPONE	18.75MG;200MG;75MG	TABLET / ORAL	AB	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213212-003	CARBIDOPA, LEVODOPA AND ENTACAPONE	25MG;200MG;100MG	TABLET / ORAL	AB	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213212-004	CARBIDOPA, LEVODOPA AND ENTACAPONE	31.25MG;200MG;125MG	TABLET / ORAL	AB	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213212-005	CARBIDOPA, LEVODOPA AND ENTACAPONE	37.5MG;200MG;150MG	TABLET / ORAL	AB	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213212-006	CARBIDOPA, LEVODOPA AND ENTACAPONE	50MG;200MG;200MG	TABLET / ORAL	AB	2022-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213212-001	CARBIDOPA, LEVODOPA AND ENTACAPONE	12.5MG;200MG;50MG	TABLET / ORAL	AB	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213212-002	CARBIDOPA, LEVODOPA AND ENTACAPONE	18.75MG;200MG;75MG	TABLET / ORAL	AB	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213212-003	CARBIDOPA, LEVODOPA AND ENTACAPONE	25MG;200MG;100MG	TABLET / ORAL	AB	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213212-004	CARBIDOPA, LEVODOPA AND ENTACAPONE	31.25MG;200MG;125MG	TABLET / ORAL	AB	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213212-005	CARBIDOPA, LEVODOPA AND ENTACAPONE	37.5MG;200MG;150MG	TABLET / ORAL	AB	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213212-006	CARBIDOPA, LEVODOPA AND ENTACAPONE	50MG;200MG;200MG	TABLET / ORAL	AB	2022-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213212-001	CARBIDOPA, LEVODOPA AND ENTACAPONE	12.5MG;200MG;50MG	TABLET / ORAL	AB	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213212-002	CARBIDOPA, LEVODOPA AND ENTACAPONE	18.75MG;200MG;75MG	TABLET / ORAL	AB	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213212-003	CARBIDOPA, LEVODOPA AND ENTACAPONE	25MG;200MG;100MG	TABLET / ORAL	AB	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213212-004	CARBIDOPA, LEVODOPA AND ENTACAPONE	31.25MG;200MG;125MG	TABLET / ORAL	AB	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213212-005	CARBIDOPA, LEVODOPA AND ENTACAPONE	37.5MG;200MG;150MG	TABLET / ORAL	AB	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213212-006	CARBIDOPA, LEVODOPA AND ENTACAPONE	50MG;200MG;200MG	TABLET / ORAL	AB	2022-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213212-001	CARBIDOPA, LEVODOPA AND ENTACAPONE	12.5MG;200MG;50MG	TABLET / ORAL	AB	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213212-002	CARBIDOPA, LEVODOPA AND ENTACAPONE	18.75MG;200MG;75MG	TABLET / ORAL	AB	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213212-003	CARBIDOPA, LEVODOPA AND ENTACAPONE	25MG;200MG;100MG	TABLET / ORAL	AB	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213212-004	CARBIDOPA, LEVODOPA AND ENTACAPONE	31.25MG;200MG;125MG	TABLET / ORAL	AB	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213212-005	CARBIDOPA, LEVODOPA AND ENTACAPONE	37.5MG;200MG;150MG	TABLET / ORAL	AB	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213212-006	CARBIDOPA, LEVODOPA AND ENTACAPONE	50MG;200MG;200MG	TABLET / ORAL	AB	2022-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213212-001	CARBIDOPA, LEVODOPA AND ENTACAPONE	12.5MG;200MG;50MG	TABLET / ORAL	AB	2022-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213212-002	CARBIDOPA, LEVODOPA AND ENTACAPONE	18.75MG;200MG;75MG	TABLET / ORAL	AB	2022-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213212-003	CARBIDOPA, LEVODOPA AND ENTACAPONE	25MG;200MG;100MG	TABLET / ORAL	AB	2022-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213212-004	CARBIDOPA, LEVODOPA AND ENTACAPONE	31.25MG;200MG;125MG	TABLET / ORAL	AB	2022-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213212-005	CARBIDOPA, LEVODOPA AND ENTACAPONE	37.5MG;200MG;150MG	TABLET / ORAL	AB	2022-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213212-006	CARBIDOPA, LEVODOPA AND ENTACAPONE	50MG;200MG;200MG	TABLET / ORAL	AB	2022-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213212-001	CARBIDOPA, LEVODOPA AND ENTACAPONE	12.5MG;200MG;50MG	TABLET / ORAL	AB	2022-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213212-002	CARBIDOPA, LEVODOPA AND ENTACAPONE	18.75MG;200MG;75MG	TABLET / ORAL	AB	2022-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213212-003	CARBIDOPA, LEVODOPA AND ENTACAPONE	25MG;200MG;100MG	TABLET / ORAL	AB	2022-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213212-004	CARBIDOPA, LEVODOPA AND ENTACAPONE	31.25MG;200MG;125MG	TABLET / ORAL	AB	2022-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213212-005	CARBIDOPA, LEVODOPA AND ENTACAPONE	37.5MG;200MG;150MG	TABLET / ORAL	AB	2022-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213212-006	CARBIDOPA, LEVODOPA AND ENTACAPONE	50MG;200MG;200MG	TABLET / ORAL	AB	2022-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213212-001	CARBIDOPA, LEVODOPA AND ENTACAPONE	12.5MG;200MG;50MG	TABLET / ORAL	AB	2022-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213212-002	CARBIDOPA, LEVODOPA AND ENTACAPONE	18.75MG;200MG;75MG	TABLET / ORAL	AB	2022-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213212-003	CARBIDOPA, LEVODOPA AND ENTACAPONE	25MG;200MG;100MG	TABLET / ORAL	AB	2022-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213212-004	CARBIDOPA, LEVODOPA AND ENTACAPONE	31.25MG;200MG;125MG	TABLET / ORAL	AB	2022-01-25	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 192 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	A213212-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213212-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213212-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213212-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213212-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213212-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213212-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213212-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213212-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213212-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213212-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213212-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213212-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213212-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213212-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213212-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213212-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213212-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213212-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213212-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213212-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213212-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213212-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213212-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213212-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213212-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213212-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213212-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213212-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213212-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213212-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213212-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213212-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213212-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213212-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213212-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213212-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213212-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213212-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213212-004	AB	1	`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
CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA, LEVODOPA AND ENTACAPONE	Rising Pharma Holdings, Inc.	2f8e82d7-6baf-456a-b8c3-4fda6e317902	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213212 application number: ANDA213212 ndc (product): 16571-692 ndc (product): 16571-693 ndc (product): 16571-691 ndc (product): 16571-694 ndc (product): 16571-689 ndc (product): 16571-690

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
16571-689	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA, LEVODOPA AND ENTACAPONE	Rising Pharma Holdings, Inc.	ANDA	Current
16571-690	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA, LEVODOPA AND ENTACAPONE	Rising Pharma Holdings, Inc.	ANDA	Current
16571-691	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA, LEVODOPA AND ENTACAPONE	Rising Pharma Holdings, Inc.	ANDA	Current
16571-692	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA, LEVODOPA AND ENTACAPONE	Rising Pharma Holdings, Inc.	ANDA	Current
16571-693	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA, LEVODOPA AND ENTACAPONE	Rising Pharma Holdings, Inc.	ANDA	Current
16571-694	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA, LEVODOPA AND ENTACAPONE	Rising Pharma Holdings, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70082	ORIG	2022-02-04