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Details for New Drug Application (NDA): 021406

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NDA 021406 describes FORTICAL, which is a drug marketed by Upsher Smith and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FORTICAL profile page.

The generic ingredient in FORTICAL is calcitonin salmon recombinant. There are fourteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the calcitonin salmon recombinant profile page.

Summary for NDA: 021406

Tradename:
FORTICAL
Applicant:
Upsher Smith
Ingredient:
calcitonin salmon recombinant
Patents:3
Formulation / Manufacturing:see details

Pharmacology for NDA: 021406

Ingredient-typeCalcitonin

Suppliers and Packaging for NDA: 021406

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FORTICAL
calcitonin salmon recombinant
SPRAY, METERED;NASAL 021406 NDA Upsher-Smith Laboratories, Inc. 0245-0008 0245-0008-35 1 BOTTLE, SPRAY in 1 CARTON (0245-0008-35) > 3.7 mL in 1 BOTTLE, SPRAY
FORTICAL
calcitonin salmon recombinant
SPRAY, METERED;NASAL 021406 NDA Physicians Total Care, Inc. 54868-5499 54868-5499-0 4 BOTTLE, SPRAY in 1 CARTON (54868-5499-0) > 3.7 mL in 1 BOTTLE, SPRAY

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SPRAY, METERED;NASALStrength200 IU/SPRAY
Approval Date:Aug 12, 2005TE:RLD:No
Patent:RE40812Patent Expiration:Feb 2, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:6,440,392Patent Expiration:Feb 2, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:NASAL ADMINISTRATION
Patent:RE43580Patent Expiration:Feb 2, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:NASAL ADMINISTRATION


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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