Application 075091

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, EXTENDED RELEASE;ORAL	50MG;200MG	No	No
002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	TABLET, EXTENDED RELEASE;ORAL	25MG;100MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075091-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB		1999-09-30
A075091-002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-04-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075091-001	AB
A075091-002	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 · 82 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	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A075091-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075091-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075091-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075091-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075091-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075091-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075091-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075091-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075091-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075091-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075091-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075091-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075091-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075091-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075091-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075091-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075091-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075091-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075091-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075091-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075091-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075091-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075091-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075091-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075091-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075091-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075091-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075091-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075091-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075091-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075091-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075091-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075091-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075091-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075091-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075091-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075091-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075091-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075091-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075091-002	AB	1	`782e0a99824c…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Mylan Pharmaceuticals Inc.	aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075091 application number: ANDA075091 ndc (product): 0378-0094 ndc (product): 0378-0088
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Safecor Health, LLC	015bc056-ee86-4006-ae7c-689b95e566f4	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075091 application number: ANDA075091
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Mylan Institutional Inc.	16f9e4d1-6953-4d4f-b4cf-ad95a856ac25	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075091 application number: ANDA075091 ndc (product): 51079-978 ndc (product): 51079-923

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0088	Carbidopa and Levodopa	carbidopa and levodopa	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0088	Carbidopa and Levodopa	carbidopa and levodopa	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0088	Carbidopa and Levodopa	carbidopa and levodopa	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0088	Carbidopa and Levodopa	carbidopa and levodopa	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0088	Carbidopa and Levodopa	carbidopa and levodopa	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0094	Carbidopa and Levodopa	carbidopa and levodopa	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0094	Carbidopa and Levodopa	carbidopa and levodopa	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0094	Carbidopa and Levodopa	carbidopa and levodopa	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0094	Carbidopa and Levodopa	carbidopa and levodopa	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0094	Carbidopa and Levodopa	carbidopa and levodopa	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-4568	Carbidopa and Levodopa	Carbidopa and Levodopa	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-4569	Carbidopa and Levodopa	Carbidopa and Levodopa	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43353-327	Carbidopa and Levodopa	carbidopa and levodopa	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-327	Carbidopa and Levodopa	carbidopa and levodopa	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
51079-923	Carbidopa and Levodopa	carbidopa and levodopa	Mylan Institutional Inc.	ANDA	Current
51079-923	Carbidopa and Levodopa	carbidopa and levodopa	Mylan Institutional Inc.	ANDA	Current
51079-923	Carbidopa and Levodopa	carbidopa and levodopa	Mylan Institutional Inc.	ANDA	Current
51079-978	Carbidopa and Levodopa	carbidopa and levodopa	Mylan Institutional Inc.	ANDA	Current
51079-978	Carbidopa and Levodopa	carbidopa and levodopa	Mylan Institutional Inc.	ANDA	Current
51079-978	Carbidopa and Levodopa	carbidopa and levodopa	Mylan Institutional Inc.	ANDA	Current
67544-672	Carbidopa and Levodopa	carbidopa and levodopa	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-672	Carbidopa and Levodopa	carbidopa and levodopa	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30753	ORIG	2004-06-24
22416	ORIG	1999-09-30
18387	ORIG	1999-09-30