FDA.reportPublic FDA data

Application 020313

Type
NDA
Sponsor
MYLAN IRELAND LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002MIACALCINCALCITONIN SALMONSPRAY, METERED;NASAL200 IU/SPRAYYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020313-002MIACALCINCALCITONIN SALMON200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD1995-08-17

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020313-002MIACALCIN200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD1995-08-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020313-002MIACALCIN200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD1995-08-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020313-002MIACALCIN200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD1995-08-17cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020313-002MIACALCIN200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD1995-08-17a50c72e98297…

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcitonin SalmonCALCITONIN SALMONApotex Corp.c82eb602-12e1-692b-d660-f8d5b5736b542026-09-10Warnings, Adverse reactionsName fallback
generic name: CALCITONIN SALMON
Calcitonin SalmonCALCITONIN SALMONFresenius Kabi USA, LLC2b8c6917-c217-45bf-a0ac-a2fa0f7d497a2026-07-15Warnings, Adverse reactionsName fallback
generic name: CALCITONIN SALMON
CALCITONIN SALMONCALCITONIN SALMONPar Health USA, LLCa6eaedb3-5c96-4859-be43-a48c9c818bc72026-06-29Warnings, Adverse reactionsName fallback
generic name: CALCITONIN SALMON
CALCITONIN SALMONCALCITONIN SALMONZydus Lifesciences Limited6a0fdcc3-9dca-4936-8601-9ec87457263d2026-03-06Name fallback
generic name: CALCITONIN SALMON
CALCITONIN SALMONCALCITONIN SALMONZydus Pharmaceuticals USA Inc.0365ebf8-0cb6-49ce-bfde-707d42b9ab002026-03-06Warnings, Adverse reactionsName fallback
generic name: CALCITONIN SALMON
Calcitonin SalmonCALCITONIN SALMONDr. Reddy's Laboratories, Inc.26f19d56-44fd-dc7a-46e8-afaaaba5734f2025-09-17Warnings, Adverse reactionsName fallback
generic name: CALCITONIN SALMON
Calcitonin SalmonCALCITONIN SALMONSagent Pharmaceuticalsfb76f8db-9288-4297-9780-f02e3bece9a32025-09-09Warnings, Adverse reactionsName fallback
generic name: CALCITONIN SALMON
CALCITONIN SALMONCALCITONIN SALMONCipla USA Inc.97a1efc7-ff5a-43e5-bf9c-0d66dbe7e6d92025-07-30Warnings, Adverse reactionsName fallback
generic name: CALCITONIN SALMON
MiacalcinCALCITONIN SALMONMylan Institutional LLC26caf31f-7f7c-48a8-a1ac-35d2ceefda2b2024-09-15Warnings, Adverse reactionsName fallback
brand name: Miacalcin
generic name: CALCITONIN SALMON
MiacalcinCALCITONIN SALMONMylan Institutional LLC753ecc6a-07be-4fc6-9032-cc6ad116a6622024-09-15Warnings, Adverse reactionsName fallback
brand name: Miacalcin
generic name: CALCITONIN SALMON
Calcitonin SalmonCALCITONIN SALMONHikma Pharmaceuticals USA Inc.7d4507aa-8e10-44a6-bc6e-3176aa8b23cc2024-07-10Warnings, Adverse reactionsName fallback
generic name: CALCITONIN SALMON
MiacalcinCALCITONIN SALMONMylan Institutional LLC89cd4f46-b88a-4c10-b25c-47352280dc4e2024-04-15Warnings, Adverse reactionsName fallback
brand name: Miacalcin
generic name: CALCITONIN SALMON
calcitonin salmonCALCITONIN SALMONAmneal Pharmaceuticals LLC22f2986f-309c-4133-9e92-1c040453f3402021-11-30Warnings, Adverse reactionsName fallback
generic name: CALCITONIN SALMON
Calcitonin SalmonCALCITONIN SALMONPar Health USA, LLCece693d8-1832-4b85-8736-819163ba56c12017-10-01Warnings, Adverse reactionsName fallback
generic name: CALCITONIN SALMON

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-6320calcitonin salmoncalcitonin salmonSandoz IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49758SUPPL2017-09-15
49728SUPPL2017-09-13
24767SUPPL2014-03-13
12439SUPPL2014-03-13
23576ORIG2014-03-12
24766SUPPL2012-04-23
34497SUPPL2012-04-20
34496SUPPL2009-12-10
20595SUPPL2007-07-06
24765SUPPL2006-01-20
2325SUPPL2003-08-28