Application 080557

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	CYANOCOBALAMIN	CYANOCOBALAMIN	INJECTABLE;INJECTION	0.1MG/ML	No	No
003	VIBISONE	CYANOCOBALAMIN	INJECTABLE;INJECTION	1MG/ML	No	Yes

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

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
A080557-002	CYANOCOBALAMIN	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982
A080557-003	VIBISONE	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A080557-003	AP

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A080557-002	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A080557-003	VIBISONE	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080557-002	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A080557-003	VIBISONE	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080557-002	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080557-003	VIBISONE	1MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080557-002	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A080557-003	VIBISONE	1MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080557-002	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A080557-003	VIBISONE	1MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080557-002	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A080557-003	VIBISONE	1MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080557-002	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A080557-003	VIBISONE	1MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080557-002	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A080557-003	VIBISONE	1MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080557-002	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A080557-003	VIBISONE	1MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080557-002	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080557-003	VIBISONE	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080557-002	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A080557-003	VIBISONE	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080557-002	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A080557-003	VIBISONE	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080557-002	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080557-003	VIBISONE	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080557-002	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080557-003	VIBISONE	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080557-002	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080557-003	VIBISONE	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080557-002	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080557-003	VIBISONE	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080557-002	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A080557-003	VIBISONE	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080557-002	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A080557-003	VIBISONE	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080557-002	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080557-003	VIBISONE	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080557-002	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A080557-003	VIBISONE	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A080557-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080557-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080557-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080557-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080557-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080557-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080557-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080557-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080557-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080557-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080557-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080557-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080557-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080557-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080557-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080557-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080557-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080557-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080557-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080557-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080557-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080557-003	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080557-003	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080557-003	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080557-003	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080557-003	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080557-003	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080557-003	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080557-003	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080557-003	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080557-003	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080557-003	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080557-003	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080557-003	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080557-003	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080557-003	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080557-003	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080557-003	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080557-003	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080557-003	AP	1	`f41ea6bd6efb…`

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
Cyanocobalamin	CYANOCOBALAMIN	Fresenius Kabi USA, LLC	acff4ff3-4435-4995-a117-dbfcdf72334a	2024-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080557 application number: ANDA080557 ndc (product): 63323-044
Cyanocobalamin	CYANOCOBALAMIN	Fresenius Kabi USA, LLC	8b1cdee5-3368-40e4-90bf-31a64df1f38a	2024-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080557 application number: ANDA080557 ndc (product): 63323-044
Cyanocobalamin	CYANOCOBALAMIN	Asclemed USA, Inc.	66e3441f-79fa-4a1b-be22-2bc683cd7abc	2021-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080557 application number: ANDA080557 ndc (product): 76420-111

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-044	Cyanocobalamin	CYANOCOBALAMIN	Fresenius Kabi USA, LLC	ANDA	Current
63323-044	Cyanocobalamin	CYANOCOBALAMIN	Fresenius Kabi USA, LLC	ANDA	Current
69263-816	B12 Inject Kit	Cyanocobalamin	Oaklock, LLC	ANDA	Current
76420-111	Cyanocobalamin	CYANOCOBALAMIN	Asclemed USA, Inc.	ANDA	Current