Application 078536

Type: ANDA
Sponsor: SUN PHARM INDS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078536-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28
A078536-002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28
A078536-003	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078536-001	AB
A078536-002	AB
A078536-003	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 1 of 4 · 129 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
2026-09-14 22:38:34	2026-08	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078536-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078536-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078536-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078536-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078536-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078536-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078536-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078536-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078536-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078536-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078536-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078536-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078536-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078536-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078536-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078536-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078536-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078536-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078536-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078536-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078536-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078536-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078536-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078536-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078536-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078536-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078536-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078536-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078536-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078536-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078536-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078536-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078536-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078536-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078536-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078536-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078536-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078536-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078536-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078536-001	AB	1	`301d65b070ca…`

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	NuCare Pharmaceuticals,Inc.	ad2ab0c4-188b-f025-e053-2a95a90a2816	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078536 application number: ANDA078536 ndc (product): 68071-2240
CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	db4198da-7ccc-4283-95ad-74bc98435cac	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078536 application number: ANDA078536 ndc (product): 63629-9154
CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Sun Pharmaceutical Industries, Inc.	829c35f9-ace0-11dd-8800-f3e252b43544	2021-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078536 application number: ANDA078536 ndc (product): 62756-518 ndc (product): 62756-519 ndc (product): 62756-517 ndc (product): 62756-985

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 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3857	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	A-S Medication Solutions	ANDA	Current
50090-3857	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	A-S Medication Solutions	ANDA	Current
62756-517	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-517	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-517	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-518	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-518	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-518	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-519	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-519	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-519	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-985	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63629-2355	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	ANDA	Current
63629-2355	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	ANDA	Current
63629-2355	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	ANDA	Current
63629-2356	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	ANDA	Current
63629-2356	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	ANDA	Current
63629-2356	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	ANDA	Current
63629-2357	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	ANDA	Current
63629-2357	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	ANDA	Current
63629-2357	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	ANDA	Current
63629-2358	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	ANDA	Current
63629-2358	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	ANDA	Current
63629-2358	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	ANDA	Current
63629-9154	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	ANDA	Current
63629-9154	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	ANDA	Current
66267-649	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-649	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-2240	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2240	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4067	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9684	CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Preferred Pharmaceuticals, Inc.	ANDA	Current