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Details for New Drug Application (NDA): 021868

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NDA 021868 describes EXUBERA, which is a drug marketed by Pfizer and is included in one NDA. There are four patents protecting this drug. Additional details are available on the EXUBERA profile page.

The generic ingredient in EXUBERA is insulin recombinant human. There are thirty-eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the insulin recombinant human profile page.

Summary for NDA: 021868

insulin recombinant human
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;INHALATIONStrength1MG/INH
Approval Date:Jan 27, 2006TE:RLD:No
Patent:6,582,728Patent Expiration:Jun 24, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:6,685,967Patent Expiration:Sep 11, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:6,257,233Patent Expiration:May 14, 2019Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021868

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 20065,740,794► subscribe
insulin recombinant human
POWDER;INHALATION021868-002Jan 27, 20065,740,794► subscribe
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 20066,423,344► subscribe
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