Application 080737

Type: ANDA
Sponsor: AM REGENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYANOCOBALAMIN	CYANOCOBALAMIN	INJECTABLE;INJECTION	1MG/ML	Yes	Yes

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

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
A080737-001	CYANOCOBALAMIN	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
A080737-001	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 2 · 43 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
2022-09-29 23:25 UTC	2022-09	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a50c72e98297…`

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	A080737-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080737-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080737-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080737-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080737-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080737-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080737-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080737-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080737-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080737-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080737-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080737-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080737-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080737-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080737-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080737-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080737-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080737-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080737-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080737-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080737-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080737-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080737-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080737-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080737-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080737-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080737-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080737-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080737-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080737-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080737-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080737-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080737-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080737-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080737-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080737-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080737-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080737-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080737-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080737-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CYANOCOBALAMIN	CYANOCOBALAMIN	HF Acquisition Co LLC, DBA HealthFirst	9d4ac337-5f4d-ef47-e053-2a95a90a6dbf	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080737 application number: ANDA080737 ndc (product): 51662-1440
CYANOCOBALAMIN	CYANOCOBALAMIN	HF Acquisition Co LLC, DBA HealthFirst	15c4de10-c059-8c2f-e063-6394a90a03a3	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080737 application number: ANDA080737
Cyanocobalamin	CYANOCOBALAMIN	American Regent, Inc.	2fb653d6-e2b2-4969-831b-c0dc37b9c0cc	2023-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080737 application number: ANDA080737 ndc (product): 0517-0032 ndc (product): 0517-0130 ndc (product): 0517-0031
Cyanocobalamin	CYANOCOBALAMIN	BluePoint Laboratories	cdd4fd12-e214-43a6-b560-d56fc0d87190	2023-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080737 application number: ANDA080737 ndc (product): 68001-542

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0517-0031	Cyanocobalamin	cyanocobalamin	American Regent, Inc.	ANDA	Current
0517-0031	Cyanocobalamin	cyanocobalamin	American Regent, Inc.	ANDA	Current
0517-0031	Cyanocobalamin	cyanocobalamin	American Regent, Inc.	ANDA	Current
0517-0032	Cyanocobalamin	cyanocobalamin	American Regent, Inc.	ANDA	Current
0517-0032	Cyanocobalamin	cyanocobalamin	American Regent, Inc.	ANDA	Current
0517-0032	Cyanocobalamin	cyanocobalamin	American Regent, Inc.	ANDA	Current
0517-0130	Cyanocobalamin	cyanocobalamin	American Regent, Inc.	ANDA	Current
0517-0130	Cyanocobalamin	cyanocobalamin	American Regent, Inc.	ANDA	Current
0517-0130	Cyanocobalamin	cyanocobalamin	American Regent, Inc.	ANDA	Current
49836-527	B-12 Compliance	Cyanocobalamin, Isopropyl Alcohol	RX PHARMA-PACK, INC.	ANDA	Current
49836-527	B-12 Compliance	Cyanocobalamin, Isopropyl Alcohol	RX PHARMA-PACK, INC.	ANDA	Current
49836-527	B-12 Compliance	Cyanocobalamin, Isopropyl Alcohol	RX PHARMA-PACK, INC.	ANDA	Current
49836-527	B-12 Compliance	Cyanocobalamin, Isopropyl Alcohol	RX PHARMA-PACK, INC.	ANDA	Current
51662-1440	CYANOCOBALAMIN	CYANOCOBALAMIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1440	CYANOCOBALAMIN	CYANOCOBALAMIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-130	Cyanocobalamin	Cyanocobalamin	General Injectables & Vaccines, Inc	ANDA	Current
68001-542	Cyanocobalamin	Cyanocobalamin	BluePoint Laboratories	ANDA	Current
69263-819	B12 Inject Kit	Cyanocobalamin	Oaklock, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68277	SUPPL	2021-08-04
68240	SUPPL	2021-08-02