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Details for New Drug Application (NDA): 021688

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NDA 021688 describes SENSIPAR, which is a drug marketed by Amgen and is included in one NDA. It is available from six suppliers. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SENSIPAR profile page.

The generic ingredient in SENSIPAR is cinacalcet hydrochloride. There are twenty-four drug master file entries for this compound. Six suppliers are listed for this compound. There are seven tentative approvals for this compound. Additional details are available on the cinacalcet hydrochloride profile page.

Summary for NDA: 021688

cinacalcet hydrochloride
Therapeutic Class:Hormonal Agents, Suppressant (Parathyroid)
Formulation / Manufacturing:see details

Pharmacology for NDA: 021688

Suppliers and Packaging for NDA: 021688

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
cinacalcet hydrochloride
TABLET;ORAL 021688 NDA State of Florida DOH Central Pharmacy 53808-0577 53808-0577-1 30 TABLET, COATED in 1 BLISTER PACK (53808-0577-1)
cinacalcet hydrochloride
TABLET;ORAL 021688 NDA State of Florida DOH Central Pharmacy 53808-0578 53808-0578-1 30 TABLET, COATED in 1 BLISTER PACK (53808-0578-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Mar 8, 2004TE:RLD:No
Patent:6,011,068Patent Expiration:Mar 8, 2018Product Flag?YSubstance Flag?YDelist Request?
Patent:6,313,146Patent Expiration:Dec 14, 2016Product Flag?YSubstance Flag?YDelist Request?
Patent:9,375,405Patent Expiration:Sep 22, 2026Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021688

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
cinacalcet hydrochloride
TABLET;ORAL021688-003Mar 8, 20046,211,244<disabled>
cinacalcet hydrochloride
TABLET;ORAL021688-001Mar 8, 20046,211,244<disabled>
cinacalcet hydrochloride
TABLET;ORAL021688-002Mar 8, 20046,211,244<disabled>
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