Application 212416

Type: ANDA
Sponsor: CUSTOPHARM INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CALCITONIN-SALMON	CALCITONIN SALMON	INJECTABLE;INJECTION	200 IU/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
A212416-001	CALCITONIN-SALMON	CALCITONIN SALMON	200 IU/ML	INJECTABLE / INJECTION	AP		2021-05-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212416-001	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	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212416-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	2021-05-14	`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	A212416-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212416-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212416-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212416-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212416-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212416-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212416-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212416-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212416-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212416-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212416-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212416-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212416-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212416-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212416-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212416-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212416-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212416-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212416-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212416-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212416-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212416-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212416-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212416-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212416-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212416-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212416-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212416-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212416-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212416-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212416-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212416-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212416-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212416-001	AP	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A212416-001	CGT	2021-11-10	`782e0a99824c…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcitonin Salmon	CALCITONIN SALMON	Hikma Pharmaceuticals USA Inc.	7d4507aa-8e10-44a6-bc6e-3176aa8b23cc	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212416 application number: ANDA212416 ndc (product): 24201-400

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24201-400	Calcitonin Salmon	calcitonin salmon	Leucadia Pharmaceuticals	ANDA	Current
24201-400	Calcitonin Salmon	calcitonin salmon	Hikma Pharmaceuticals USA Inc.(dba Leucadia Pharmaceuticals)	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67813	ORIG	2021-06-15