Application 017808

Type: NDA
Sponsor: MYLAN IRELAND LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIACALCIN	CALCITONIN SALMON	INJECTABLE;INJECTION	100 IU/ML	Yes	No
002	MIACALCIN	CALCITONIN SALMON	INJECTABLE;INJECTION	200 IU/ML	Yes	Yes

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

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
N017808-001	MIACALCIN	CALCITONIN SALMON	100 IU/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-07-03
N017808-002	MIACALCIN	CALCITONIN SALMON	200 IU/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017808-002	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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N017808-001	MIACALCIN	100 IU/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017808-002	MIACALCIN	200 IU/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017808-001	MIACALCIN	100 IU/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017808-002	MIACALCIN	200 IU/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017808-001	MIACALCIN	100 IU/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017808-002	MIACALCIN	200 IU/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017808-001	MIACALCIN	100 IU/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017808-002	MIACALCIN	200 IU/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017808-001	MIACALCIN	100 IU/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017808-002	MIACALCIN	200 IU/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017808-001	MIACALCIN	100 IU/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017808-002	MIACALCIN	200 IU/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017808-001	MIACALCIN	100 IU/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017808-002	MIACALCIN	200 IU/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017808-001	MIACALCIN	100 IU/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017808-002	MIACALCIN	200 IU/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017808-001	MIACALCIN	100 IU/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-07-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017808-002	MIACALCIN	200 IU/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017808-001	MIACALCIN	100 IU/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-07-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017808-002	MIACALCIN	200 IU/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017808-001	MIACALCIN	100 IU/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-07-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017808-002	MIACALCIN	200 IU/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017808-001	MIACALCIN	100 IU/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-07-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017808-002	MIACALCIN	200 IU/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017808-001	MIACALCIN	100 IU/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-07-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017808-002	MIACALCIN	200 IU/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017808-001	MIACALCIN	100 IU/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-07-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017808-002	MIACALCIN	200 IU/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017808-001	MIACALCIN	100 IU/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-07-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017808-002	MIACALCIN	200 IU/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017808-001	MIACALCIN	100 IU/ML	INJECTABLE / INJECTION		RLD	1986-07-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017808-002	MIACALCIN	200 IU/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017808-001	MIACALCIN	100 IU/ML	INJECTABLE / INJECTION		RLD	1986-07-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017808-002	MIACALCIN	200 IU/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017808-001	MIACALCIN	100 IU/ML	INJECTABLE / INJECTION		RLD	1986-07-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017808-002	MIACALCIN	200 IU/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017808-001	MIACALCIN	100 IU/ML	INJECTABLE / INJECTION		RLD	1986-07-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017808-002	MIACALCIN	200 IU/ML	INJECTABLE / INJECTION		RLD, RS	1991-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017808-001	MIACALCIN	100 IU/ML	INJECTABLE / INJECTION		RLD	1986-07-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017808-002	MIACALCIN	200 IU/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-03-29	`bb7c543d1eb4…`

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	N017808-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017808-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017808-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017808-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017808-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017808-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017808-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017808-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017808-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017808-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017808-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017808-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017808-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017808-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017808-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017808-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017808-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017808-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N017808-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017808-002	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017808-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017808-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017808-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017808-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017808-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017808-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017808-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017808-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017808-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017808-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017808-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017808-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017808-002	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017808-002	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miacalcin	CALCITONIN SALMON	Mylan Institutional LLC	26caf31f-7f7c-48a8-a1ac-35d2ceefda2b	2024-09-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017808 application number: NDA017808 ndc (product): 72078-039
Miacalcin	CALCITONIN SALMON	Mylan Institutional LLC	753ecc6a-07be-4fc6-9032-cc6ad116a662	2024-09-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017808 application number: NDA017808 ndc (product): 72078-038
Miacalcin	CALCITONIN SALMON	Mylan Institutional LLC	89cd4f46-b88a-4c10-b25c-47352280dc4e	2024-04-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017808 application number: NDA017808 ndc (product): 67457-675

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67457-675	Miacalcin	calcitonin salmon	Mylan Institutional LLC	NDA	Current
67457-675	Miacalcin	calcitonin salmon	Mylan Institutional LLC	NDA	Current
67457-675	Miacalcin	calcitonin salmon	Mylan Institutional LLC	NDA	Current
72078-038	Miacalcin	calcitonin salmon	Mylan Institutional LLC	NDA	Current
72078-038	Miacalcin	calcitonin salmon	Mylan Institutional LLC	NDA	Current
72078-039	Miacalcin	calcitonin salmon	Mylan Institutional LLC	NDA	Current
72078-039	Miacalcin	calcitonin salmon	Mylan Institutional LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49752	SUPPL	2017-09-15
49718	SUPPL	2017-09-12
11066	SUPPL	2015-02-03
708	SUPPL	2015-02-03
11065	SUPPL	2014-03-13
707	SUPPL	2014-03-13
44014	ORIG	2014-03-12
13903	SUPPL	2012-04-23
11064	SUPPL	2012-04-20
33349	SUPPL	2009-12-10
706	SUPPL	2003-06-08
40760	SUPPL	1997-07-14