Application 214655

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A214655-001	CYANOCOBALAMIN	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP		2022-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214655-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214655-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214655-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214655-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214655-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214655-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214655-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214655-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214655-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214655-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214655-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214655-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214655-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214655-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214655-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214655-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214655-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214655-001	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214655-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214655-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214655-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214655-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214655-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214655-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214655-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214655-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214655-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214655-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214655-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214655-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214655-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214655-001	AP	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cyanocobalamin	CYANOCOBALAMIN	Zydus Pharmaceuticals USA Inc.	e6712877-ace0-441c-99a9-adf567c0b9a2	2022-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214655 application number: ANDA214655 ndc (product): 70710-1665 ndc (product): 70710-1663 ndc (product): 70710-1664
cyanocobalamin	CYANOCOBALAMIN	Zydus Lifesciences Limited	ef300a08-8212-40a9-847a-1b62348896dd	2022-04-19		Exact identifier application applno (ANDA): 214655 application number: ANDA214655 ndc (product): 70771-1689 ndc (product): 70771-1688 ndc (product): 70771-1690

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-165	cyanocobalamin	cyanocobalamin	Northstar Rx LLC.	ANDA	Current
16714-302	cyanocobalamin	cyanocobalamin	Northstar Rx LLC.	ANDA	Current
16714-609	cyanocobalamin	cyanocobalamin	Northstar Rx LLC.	ANDA	Current
70710-1663	cyanocobalamin	cyanocobalamin	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1664	cyanocobalamin	cyanocobalamin	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1665	cyanocobalamin	cyanocobalamin	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70771-1688	cyanocobalamin	cyanocobalamin	Zydus Lifesciences Limited	ANDA	Current
70771-1689	cyanocobalamin	cyanocobalamin	Zydus Lifesciences Limited	ANDA	Current
70771-1690	cyanocobalamin	cyanocobalamin	Zydus Lifesciences Limited	ANDA	Current