Application 212918

Type: ANDA
Sponsor: BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATOVAQUONE	ATOVAQUONE	SUSPENSION;ORAL	750MG/5ML	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
A212918-001	ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB		2021-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212918-001	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.

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	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212918-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212918-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212918-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212918-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212918-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212918-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212918-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212918-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212918-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212918-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212918-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212918-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212918-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212918-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212918-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212918-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212918-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212918-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212918-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212918-001	AB	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212918-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212918-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212918-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212918-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212918-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212918-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212918-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212918-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212918-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212918-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212918-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212918-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212918-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212918-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atovaquone	ATOVAQUONE	Golden State Medical Supply, Inc.	ddbfe1a9-df9b-79b0-e053-2995a90acc9b	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212918 application number: ANDA212918 ndc (product): 51407-642
Atovaquone	ATOVAQUONE	Bionpharma Inc.	bff4f4fc-6307-f414-e053-2a95a90ac0de	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212918 application number: ANDA212918 ndc (product): 69452-252
Atovaquone	ATOVAQUONE	Kesin Pharma	16b69156-e5de-c601-e063-6394a90afeae	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212918 application number: ANDA212918
Atovaquone	ATOVAQUONE	A2A Integrated Pharmaceuticals, LLC	27d64592-5078-6122-e063-6394a90ae074	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212918 application number: ANDA212918

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-642	Atovaquone	Atovaquone	Golden State Medical Supply, Inc.	ANDA	Current
69452-252	Atovaquone	Atovaquone	Bionpharma Inc.	ANDA	Current
69452-252	Atovaquone	Atovaquone	Bionpharma Inc.	ANDA	Current
69452-252	Atovaquone	Atovaquone	Bionpharma Inc.	ANDA	Current