Application 080515

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	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
A080515-002	CYANOCOBALAMIN	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	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
A080515-002	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 1 of 2 · 42 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
2026-08-18 06:07:40	2026-07	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A080515-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080515-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080515-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080515-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080515-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080515-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080515-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080515-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080515-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080515-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080515-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080515-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080515-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080515-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080515-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080515-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080515-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080515-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080515-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080515-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080515-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080515-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080515-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080515-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080515-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080515-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080515-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080515-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080515-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080515-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080515-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080515-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080515-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080515-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080515-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080515-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080515-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080515-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080515-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080515-002	AP	1	`e64feba35796…`

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	HF Acquisition Co LLC, DBA HealthFirst	953aa8c6-31ce-0c3b-e053-2a95a90ab35f	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080515 application number: ANDA080515 ndc (product): 51662-1394
Cyanocobalamin	CYANOCOBALAMIN	Hikma Pharmaceuticals USA Inc.	a66eb3c4-3e1d-4d49-b963-4fa2334cc9b6	2023-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080515 application number: ANDA080515 ndc (product): 0143-9621 ndc (product): 0143-9619 ndc (product): 0143-9620

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
0143-9619	Cyanocobalamin	cyanocobalamin	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9619	Cyanocobalamin	cyanocobalamin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9620	Cyanocobalamin	cyanocobalamin	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9620	Cyanocobalamin	cyanocobalamin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9621	Cyanocobalamin	cyanocobalamin	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9621	Cyanocobalamin	cyanocobalamin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
50090-2709	Cyanocobalamin	cyanocobalamin	A-S Medication Solutions	ANDA	Current
50090-2709	Cyanocobalamin	cyanocobalamin	A-S Medication Solutions	ANDA	Current
51662-1394	CYANOCOBALAMIN	CYANOCOBALAMIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1394	CYANOCOBALAMIN	CYANOCOBALAMIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1394	CYANOCOBALAMIN	CYANOCOBALAMIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1394	CYANOCOBALAMIN	CYANOCOBALAMIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
70529-290	Vitamin Deficiency Injectable System - B12	Cyanocobalamin	IT3 Medical LLC	ANDA	Current
70529-290	Vitamin Deficiency Injectable System - B12	Cyanocobalamin	IT3 Medical LLC	ANDA	Current
70529-290	Vitamin Deficiency Injectable System - B12	Cyanocobalamin	IT3 Medical LLC	ANDA	Current
70529-293	Vitamin Deficiency System	Cyanocobalamin	IT3 Medical LLC	ANDA	Current
70529-293	Vitamin Deficiency System	Cyanocobalamin	IT3 Medical LLC	ANDA	Current
70529-293	Vitamin Deficiency System	Cyanocobalamin	IT3 Medical LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22636	ORIG	2003-08-04