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Last Updated: October 27, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020313

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NDA 020313 describes MIACALCIN, which is a drug marketed by Mylan Ireland Ltd and is included in two NDAs. It is available from one supplier. Additional details are available on the MIACALCIN profile page.

The generic ingredient in MIACALCIN is calcitonin salmon. There are fourteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the calcitonin salmon profile page.
Summary for 020313
Applicant:Mylan Ireland Ltd
Ingredient:calcitonin salmon
Formulation / Manufacturing:see details
Paragraph IV (Patent) Challenges for 020313
Tradename Dosage Ingredient NDA Submissiondate
MIACALCIN SPRAY, METERED;NASAL calcitonin salmon 020313

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SPRAY, METERED;NASALStrength200 IU/SPRAY
Approval Date:Aug 17, 1995TE:RLD:Yes

Expired US Patents for NDA 020313

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Ireland Ltd MIACALCIN calcitonin salmon SPRAY, METERED;NASAL 020313-002 Aug 17, 1995   Start Trial   Start Trial
Mylan Ireland Ltd MIACALCIN calcitonin salmon SPRAY, METERED;NASAL 020313-002 Aug 17, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson

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