Application 214390

Type: ANDA
Sponsor: GLAND PHARMA LTD

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 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
A214390-001	CYANOCOBALAMIN	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP		2020-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214390-001	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
2026-02-19 14:30 UTC	2026-02	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`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	A214390-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214390-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214390-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214390-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214390-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214390-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214390-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214390-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214390-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214390-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214390-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214390-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214390-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214390-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214390-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214390-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214390-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214390-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214390-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214390-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214390-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A214390-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A214390-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214390-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214390-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214390-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214390-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214390-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214390-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214390-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214390-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214390-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214390-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214390-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214390-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214390-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214390-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyanocobalamin	CYANOCOBALAMIN	Plano Pharmaceuticals Inc.	4cbc05f6-4b31-4a5f-e063-6394a90a676c	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214390 application number: ANDA214390
Cyanocobalamin	CYANOCOBALAMIN	Meitheal Pharmaceuticals Inc.	c6436212-9246-4e29-8540-9af992b667eb	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214390 application number: ANDA214390 ndc (product): 71288-303
Cyanocobalamin	CYANOCOBALAMIN	Gland Pharma Limited	cd8d188a-fa5d-4580-bcb1-ac8617118cbb	2022-11-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214390 application number: ANDA214390 ndc (product): 68083-562 ndc (product): 68083-561 ndc (product): 68083-449
Cyanocobalamin	CYANOCOBALAMIN	Meitheal Pharmaceuticals Inc.	ccf5b124-083d-4465-a666-c1bc6e84d630	2022-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214390 application number: ANDA214390 ndc (product): 71288-303

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68083-449	Cyanocobalamin	Cyanocobalamin	Gland Pharma Limited	ANDA	Current
68083-449	Cyanocobalamin	Cyanocobalamin	Gland Pharma Limited	ANDA	Current
68083-449	Cyanocobalamin	Cyanocobalamin	Gland Pharma Limited	ANDA	Current
68083-561	cyanocobalamin	cyanocobalamin	Gland Pharma Limited	ANDA	Current
68083-562	cyanocobalamin	cyanocobalamin	Gland Pharma Limited	ANDA	Current
71288-303	Cyanocobalamin	Cyanocobalamin	Meitheal Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72360	SUPPL	2022-10-17