Application 203261

Type: ANDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARBIDOPA	CARBIDOPA	TABLET;ORAL	25MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203261-001	CARBIDOPA	CARBIDOPA	25MG	TABLET / ORAL			2014-03-10

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 2 · 41 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	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203261-001	CARBIDOPA	25MG	TABLET / ORAL	AB	2014-03-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203261-001	CARBIDOPA	25MG	TABLET / ORAL	AB	2014-03-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203261-001	CARBIDOPA	25MG	TABLET / ORAL	AB	2014-03-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203261-001	CARBIDOPA	25MG	TABLET / ORAL	AB	2014-03-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203261-001	CARBIDOPA	25MG	TABLET / ORAL	AB	2014-03-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203261-001	CARBIDOPA	25MG	TABLET / ORAL	AB	2014-03-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203261-001	CARBIDOPA	25MG	TABLET / ORAL	AB	2014-03-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203261-001	CARBIDOPA	25MG	TABLET / ORAL	AB	2014-03-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203261-001	CARBIDOPA	25MG	TABLET / ORAL	AB	2014-03-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203261-001	CARBIDOPA	25MG	TABLET / ORAL	AB	2014-03-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203261-001	CARBIDOPA	25MG	TABLET / ORAL	AB	2014-03-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203261-001	CARBIDOPA	25MG	TABLET / ORAL	AB	2014-03-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203261-001	CARBIDOPA	25MG	TABLET / ORAL	AB	2014-03-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203261-001	CARBIDOPA	25MG	TABLET / ORAL		2014-03-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203261-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203261-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203261-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203261-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203261-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203261-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203261-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203261-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203261-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203261-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203261-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203261-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203261-001	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa	CARBIDOPA	Edenbridge Pharmaceuticals LLC.	55b99f22-9eb2-4df6-9979-bc4c3af5e454	2025-12-17	Warnings, Adverse reactions	Name fallback brand name: Carbidopa generic name: CARBIDOPA
CARBIDOPA	CARBIDOPA	Zydus Lifesciences Limited	83012ccc-aba2-45bb-9326-dc30cdeb4e3b	2024-11-26		Name fallback brand name: CARBIDOPA generic name: CARBIDOPA
Carbidopa	CARBIDOPA	Lupin Pharmaceuticals,Inc.	e95b1ab8-0fd9-4399-897a-5ae73b36af45	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: Carbidopa generic name: CARBIDOPA
CARBIDOPA	CARBIDOPA	Zydus Pharmaceuticals USA Inc.	c0b1ef99-3092-431a-8fb6-897affd52595	2023-09-16	Warnings, Adverse reactions	Name fallback brand name: CARBIDOPA generic name: CARBIDOPA
Carbidopa	CARBIDOPA	NorthStar Rx LLC	33ee4598-cbcc-45e0-a48e-dc0101e1f204	2022-11-03	Warnings, Adverse reactions	Name fallback brand name: Carbidopa generic name: CARBIDOPA
Carbidopa	CARBIDOPA	Aurobindo Pharma Limited	ed98c7e1-78a6-43a5-92cd-4f085af6f09d	2021-04-29	Warnings, Adverse reactions	Name fallback brand name: Carbidopa generic name: CARBIDOPA
Carbidopa	CARBIDOPA TABLETS	Oceanside Pharmaceuticals	d5204e5e-10ef-4758-8fc6-cb710048c687	2020-07-02	Warnings, Adverse reactions	Name fallback brand name: Carbidopa
Lodosyn	CARBIDOPA	Bausch Health US, LLC	ff8e105b-7415-42d4-bbb2-b36cfb8945a5	2020-07-01	Warnings, Adverse reactions	Name fallback generic name: CARBIDOPA
Carbidopa	CARBIDOPA	Novel Laboratories, Inc.	7e5c9666-7a7c-4b64-87e4-7be6ae53603e	2017-06-01	Warnings, Adverse reactions	Name fallback brand name: Carbidopa generic name: CARBIDOPA

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43975-220	Carbidopa	Carbidopa	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-220	Carbidopa	Carbidopa	Amerigen Pharmaceuticals Inc.	ANDA	Current
43975-220	Carbidopa	Carbidopa	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-220	Carbidopa	Carbidopa	ANI Pharmaceuticals, Inc.	ANDA	Current
63629-1932	Carbidopa	Carbidopa	Bryant Ranch Prepack	ANDA	Current
63629-1932	Carbidopa	Carbidopa	Bryant Ranch Prepack	ANDA	Current
63629-1932	Carbidopa	Carbidopa	Bryant Ranch Prepack	ANDA	Current
63629-9193	Carbidopa	Carbidopa	Bryant Ranch Prepack	ANDA	Current