Application 078893

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	TABLET, ORALLY DISINTEGRATING;ORAL	10MG;100MG	No	No
002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	TABLET, ORALLY DISINTEGRATING;ORAL	25MG;100MG	No	No
003	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	TABLET, ORALLY DISINTEGRATING;ORAL	25MG;250MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A078893-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18
A078893-002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18
A078893-003	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078893-001	AB
A078893-002	AB
A078893-003	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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2008-09-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2008-09-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2008-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL			2008-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2008-09-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2008-09-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2008-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2008-09-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2008-09-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2008-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2008-09-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2008-09-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2008-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2008-09-18	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2008-09-18	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A078893-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078893-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078893-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078893-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078893-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078893-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078893-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078893-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078893-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078893-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078893-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078893-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078893-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078893-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078893-003	AB	1	`31067a03dcf5…`
2019-12-13 00:20 UTC	2019-12	A078893-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078893-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078893-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078893-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078893-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078893-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078893-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078893-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078893-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078893-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078893-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078893-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078893-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078893-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078893-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078893-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078893-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078893-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078893-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078893-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078893-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078893-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078893-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078893-003	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078893-001	AB	1	`a50c72e98297…`

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 and Levodopa	CARBIDOPA AND LEVODOPA	Rising Pharma Holdings, Inc.	302bfe03-d222-4a87-80ff-f2dbfb9a07f4	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078893 application number: ANDA078893

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-5051	Carbidopa and Levodopa	carbidopa and levodopa	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5052	Carbidopa and Levodopa	carbidopa and levodopa	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5053	Carbidopa and Levodopa	carbidopa and levodopa	Mylan Pharmaceuticals Inc.	ANDA	Current