Application 080855

Type: ANDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BETALIN 12	CYANOCOBALAMIN	INJECTABLE;INJECTION	0.1MG/ML	No	No
002	BETALIN 12	CYANOCOBALAMIN	INJECTABLE;INJECTION	1MG/ML	No	No

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
A080855-001	BETALIN 12	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE / INJECTION		Approved before 1982
A080855-002	BETALIN 12	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION		Approved before 1982

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	RLD / RS	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A080855-001	BETALIN 12	0.1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A080855-002	BETALIN 12	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080855-001	BETALIN 12	0.1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A080855-002	BETALIN 12	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080855-001	BETALIN 12	0.1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080855-002	BETALIN 12	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080855-001	BETALIN 12	0.1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A080855-002	BETALIN 12	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080855-001	BETALIN 12	0.1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A080855-002	BETALIN 12	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080855-001	BETALIN 12	0.1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A080855-002	BETALIN 12	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080855-001	BETALIN 12	0.1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A080855-002	BETALIN 12	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080855-001	BETALIN 12	0.1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A080855-002	BETALIN 12	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080855-001	BETALIN 12	0.1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A080855-002	BETALIN 12	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080855-001	BETALIN 12	0.1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080855-002	BETALIN 12	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080855-001	BETALIN 12	0.1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A080855-002	BETALIN 12	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080855-001	BETALIN 12	0.1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A080855-002	BETALIN 12	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080855-001	BETALIN 12	0.1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080855-002	BETALIN 12	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080855-001	BETALIN 12	0.1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080855-002	BETALIN 12	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080855-001	BETALIN 12	0.1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080855-002	BETALIN 12	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080855-001	BETALIN 12	0.1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080855-002	BETALIN 12	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080855-001	BETALIN 12	0.1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A080855-002	BETALIN 12	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080855-001	BETALIN 12	0.1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A080855-002	BETALIN 12	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080855-001	BETALIN 12	0.1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080855-002	BETALIN 12	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080855-001	BETALIN 12	0.1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A080855-002	BETALIN 12	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`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 2 · 36 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	54f088b1-7cf8-3837-e063-6294a90a88e7	2026-09-02	Adverse reactions	Name fallback generic name: CYANOCOBALAMIN
Cyanocobalamin	CYANOCOBALAMIN	Lifestar Pharma LLC	b1e35c97-2157-454e-967f-53a4300827de	2026-08-06	Warnings, Adverse reactions	Name fallback generic name: CYANOCOBALAMIN
Cyanocobalamin	CYANOCOBALAMIN	NorthStar RxLLC	ce0183b3-4410-466a-b57d-cd360d461b7c	2026-08-06	Warnings, Adverse reactions	Name fallback generic name: CYANOCOBALAMIN
Non-proprietary name	CYANOCOBALAMIN	Xseer Pharmaceuticals	3bb870d8-128d-75ea-e063-6394a90a707b	2026-05-13		Name fallback generic name: CYANOCOBALAMIN
Cyanocobalamin	CYANOCOBALAMIN	Plano Pharmaceuticals Inc.	4cbc05f6-4b31-4a5f-e063-6394a90a676c	2026-03-25	Warnings, Adverse reactions	Name fallback generic name: CYANOCOBALAMIN
cyanocobalamin	CYANOCOBALAMIN	Sportpharm LLC	647842f4-b211-4f52-8b73-975fae767023	2026-02-05	Warnings, Adverse reactions	Name fallback generic name: CYANOCOBALAMIN
Cyanocobalamin	CYANOCOBALAMIN	A-S Medication Solutions	a61181f5-7e2d-45f9-929a-cb8bc70c992e	2026-01-06	Warnings, Adverse reactions	Name fallback generic name: CYANOCOBALAMIN
Cyanocobalamin	CYANOCOBALAMIN	SOLA Pharmaceuticals	e559c6c8-2973-77fb-e053-2995a90af43d	2025-12-08	Warnings, Adverse reactions	Name fallback generic name: CYANOCOBALAMIN
Cyanocobalamin	CYANOCOBALAMIN	BluePoint Laboratories	5c603ad0-9023-44cc-955c-3988d5dcf0d3	2025-12-05	Warnings, Adverse reactions	Name fallback generic name: CYANOCOBALAMIN
CYANOCOBALAMIN	CYANOCOBALAMIN	Henry Schein, Inc.	ff32f34b-89b3-4617-ad42-2e8bcb88627e	2025-10-16	Warnings, Adverse reactions	Name fallback generic name: CYANOCOBALAMIN
Cyanocobalamin	CYANOCOBALAMIN	Henry Schein, Inc.	92f08572-cfd9-4a99-bb49-937ab94eeb62	2025-09-10	Warnings, Adverse reactions	Name fallback generic name: CYANOCOBALAMIN
cyanocobalamin	CYANOCOBALAMIN	Somerset Therapeutics, LLC	41ac0dc1-0a71-4c69-8e25-ba838f5f16a3	2025-09-04	Warnings, Adverse reactions	Name fallback generic name: CYANOCOBALAMIN
CYANOCOBALAMIN	CYANOCOBALAMIN	Somerset Therapeutics, LLC	617e44f8-df80-4764-85b9-be0fb6da8db3	2025-08-29	Warnings, Adverse reactions	Name fallback generic name: CYANOCOBALAMIN
Cyanocobalamin	CYANOCOBALAMIN	Meitheal Pharmaceuticals Inc.	064c6841-3ed2-417f-a77c-a730785b6036	2025-06-12	Warnings, Adverse reactions	Name fallback generic name: CYANOCOBALAMIN
CYANOCOBALAMIN	CYANOCOBALAMIN	HF Acquisition Co LLC, DBA HealthFirst	9d4ac337-5f4d-ef47-e053-2a95a90a6dbf	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: CYANOCOBALAMIN
Cyanocobalamin	CYANOCOBALAMIN	Vitruvias Therapeutics	2117af8a-723f-4e2f-98a6-83ad2c423751	2024-12-20	Warnings, Adverse reactions	Name fallback generic name: CYANOCOBALAMIN
Cyanocobalamin	CYANOCOBALAMIN	Fresenius Kabi USA, LLC	acff4ff3-4435-4995-a117-dbfcdf72334a	2024-12-15	Warnings, Adverse reactions	Name fallback generic name: CYANOCOBALAMIN
Cyanocobalamin	CYANOCOBALAMIN	Fresenius Kabi USA, LLC	8b1cdee5-3368-40e4-90bf-31a64df1f38a	2024-12-12	Warnings, Adverse reactions	Name fallback generic name: CYANOCOBALAMIN
Cyanocobalamin	CYANOCOBALAMIN	Meitheal Pharmaceuticals Inc.	9c37fd25-2143-410c-8d89-d39aa5c7b453	2024-11-22	Warnings, Adverse reactions	Name fallback generic name: CYANOCOBALAMIN
Cyanocobalamin	CYANOCOBALAMIN	Meitheal Pharmaceuticals Inc.	c6436212-9246-4e29-8540-9af992b667eb	2024-06-03	Warnings, Adverse reactions	Name fallback generic name: CYANOCOBALAMIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.