Application 090833

Type: ANDA
Sponsor: WOCKHARDT LTD

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	18.75MG;200MG;75MG	No	No
002	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA	TABLET;ORAL	25MG;200MG;100MG	No	No
003	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA	TABLET;ORAL	31.25MG;200MG;125MG	No	No
004	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA	TABLET;ORAL	37.5MG;200MG;150MG	No	No
005	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 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A090833-001	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA	18.75MG;200MG;75MG	TABLET / ORAL	2012-11-20
A090833-002	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA	25MG;200MG;100MG	TABLET / ORAL	2012-11-20
A090833-003	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA	31.25MG;200MG;125MG	TABLET / ORAL	2012-11-20
A090833-004	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA	37.5MG;200MG;150MG	TABLET / ORAL	2012-11-20
A090833-005	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA	50MG;200MG;200MG	TABLET / ORAL	2012-11-20

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 4 of 6 · 220 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
2021-03-12 10:30 UTC	2021-03	A090833-001	CARBIDOPA, LEVODOPA AND ENTACAPONE	18.75MG;200MG;75MG	TABLET / ORAL		2012-11-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090833-002	CARBIDOPA, LEVODOPA AND ENTACAPONE	25MG;200MG;100MG	TABLET / ORAL		2012-11-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090833-003	CARBIDOPA, LEVODOPA AND ENTACAPONE	31.25MG;200MG;125MG	TABLET / ORAL		2012-11-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090833-004	CARBIDOPA, LEVODOPA AND ENTACAPONE	37.5MG;200MG;150MG	TABLET / ORAL		2012-11-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090833-005	CARBIDOPA, LEVODOPA AND ENTACAPONE	50MG;200MG;200MG	TABLET / ORAL		2012-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090833-001	CARBIDOPA, LEVODOPA AND ENTACAPONE	18.75MG;200MG;75MG	TABLET / ORAL		2012-11-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090833-002	CARBIDOPA, LEVODOPA AND ENTACAPONE	25MG;200MG;100MG	TABLET / ORAL		2012-11-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090833-003	CARBIDOPA, LEVODOPA AND ENTACAPONE	31.25MG;200MG;125MG	TABLET / ORAL		2012-11-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090833-004	CARBIDOPA, LEVODOPA AND ENTACAPONE	37.5MG;200MG;150MG	TABLET / ORAL		2012-11-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090833-005	CARBIDOPA, LEVODOPA AND ENTACAPONE	50MG;200MG;200MG	TABLET / ORAL		2012-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090833-001	CARBIDOPA, LEVODOPA AND ENTACAPONE	18.75MG;200MG;75MG	TABLET / ORAL		2012-11-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090833-002	CARBIDOPA, LEVODOPA AND ENTACAPONE	25MG;200MG;100MG	TABLET / ORAL		2012-11-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090833-003	CARBIDOPA, LEVODOPA AND ENTACAPONE	31.25MG;200MG;125MG	TABLET / ORAL		2012-11-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090833-004	CARBIDOPA, LEVODOPA AND ENTACAPONE	37.5MG;200MG;150MG	TABLET / ORAL		2012-11-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090833-005	CARBIDOPA, LEVODOPA AND ENTACAPONE	50MG;200MG;200MG	TABLET / ORAL		2012-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090833-001	CARBIDOPA, LEVODOPA AND ENTACAPONE	18.75MG;200MG;75MG	TABLET / ORAL		2012-11-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090833-002	CARBIDOPA, LEVODOPA AND ENTACAPONE	25MG;200MG;100MG	TABLET / ORAL		2012-11-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090833-003	CARBIDOPA, LEVODOPA AND ENTACAPONE	31.25MG;200MG;125MG	TABLET / ORAL		2012-11-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090833-004	CARBIDOPA, LEVODOPA AND ENTACAPONE	37.5MG;200MG;150MG	TABLET / ORAL		2012-11-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090833-005	CARBIDOPA, LEVODOPA AND ENTACAPONE	50MG;200MG;200MG	TABLET / ORAL		2012-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090833-001	CARBIDOPA, LEVODOPA AND ENTACAPONE	18.75MG;200MG;75MG	TABLET / ORAL		2012-11-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090833-002	CARBIDOPA, LEVODOPA AND ENTACAPONE	25MG;200MG;100MG	TABLET / ORAL		2012-11-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090833-003	CARBIDOPA, LEVODOPA AND ENTACAPONE	31.25MG;200MG;125MG	TABLET / ORAL		2012-11-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090833-004	CARBIDOPA, LEVODOPA AND ENTACAPONE	37.5MG;200MG;150MG	TABLET / ORAL		2012-11-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090833-005	CARBIDOPA, LEVODOPA AND ENTACAPONE	50MG;200MG;200MG	TABLET / ORAL		2012-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090833-001	CARBIDOPA, LEVODOPA AND ENTACAPONE	18.75MG;200MG;75MG	TABLET / ORAL	AB	2012-11-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090833-002	CARBIDOPA, LEVODOPA AND ENTACAPONE	25MG;200MG;100MG	TABLET / ORAL	AB	2012-11-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090833-003	CARBIDOPA, LEVODOPA AND ENTACAPONE	31.25MG;200MG;125MG	TABLET / ORAL	AB	2012-11-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090833-004	CARBIDOPA, LEVODOPA AND ENTACAPONE	37.5MG;200MG;150MG	TABLET / ORAL	AB	2012-11-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090833-005	CARBIDOPA, LEVODOPA AND ENTACAPONE	50MG;200MG;200MG	TABLET / ORAL	AB	2012-11-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090833-001	CARBIDOPA, LEVODOPA AND ENTACAPONE	18.75MG;200MG;75MG	TABLET / ORAL		2012-11-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090833-002	CARBIDOPA, LEVODOPA AND ENTACAPONE	25MG;200MG;100MG	TABLET / ORAL		2012-11-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090833-003	CARBIDOPA, LEVODOPA AND ENTACAPONE	31.25MG;200MG;125MG	TABLET / ORAL		2012-11-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090833-004	CARBIDOPA, LEVODOPA AND ENTACAPONE	37.5MG;200MG;150MG	TABLET / ORAL		2012-11-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090833-005	CARBIDOPA, LEVODOPA AND ENTACAPONE	50MG;200MG;200MG	TABLET / ORAL		2012-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090833-001	CARBIDOPA, LEVODOPA AND ENTACAPONE	18.75MG;200MG;75MG	TABLET / ORAL		2012-11-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090833-002	CARBIDOPA, LEVODOPA AND ENTACAPONE	25MG;200MG;100MG	TABLET / ORAL		2012-11-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090833-003	CARBIDOPA, LEVODOPA AND ENTACAPONE	31.25MG;200MG;125MG	TABLET / ORAL		2012-11-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090833-004	CARBIDOPA, LEVODOPA AND ENTACAPONE	37.5MG;200MG;150MG	TABLET / ORAL		2012-11-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090833-005	CARBIDOPA, LEVODOPA AND ENTACAPONE	50MG;200MG;200MG	TABLET / ORAL		2012-11-20	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A090833-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090833-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090833-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090833-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090833-005	AB	1	`ea99ee380514…`

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 · 4 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	Name fallback brand name: CARBIDOPA, LEVODOPA AND ENTACAPONE
Carbidopa, Levodopa and Entacapone	CARBIDOPA, LEVODOPA AND ENTACAPONE	Macleods Pharmaceuticals Limited	f0d9d7a8-1d06-4119-b2bc-42b3ec08d45b	2026-04-08	Warnings, Adverse reactions	Name fallback brand name: Carbidopa, Levodopa and Entacapone
carbidopa, levodopa and entacapone	CARBIDOPA, LEVODOPA AND ENTACAPONE	Alembic Pharmaceuticals Inc.	9d4e886e-edec-471d-b619-bf4828a6b7ce	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: carbidopa, levodopa and entacapone
carbidopa, levodopa and entacapone	CARBIDOPA, LEVODOPA AND ENTACAPONE	Alembic Pharmaceuticals Limited	9ff83838-b7d0-4eec-98f2-fcc85789a189	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: carbidopa, levodopa and entacapone

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9299	ORIG	2012-12-18