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Generated: November 21, 2018

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Details for New Drug Application (NDA): 020972

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NDA 020972 describes SUSTIVA, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. It is available from two suppliers. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the SUSTIVA profile page.

The generic ingredient in SUSTIVA is efavirenz. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the efavirenz profile page.
Summary for 020972
Tradename:SUSTIVA
Applicant:Bristol Myers Squibb
Ingredient:efavirenz
Patents:4
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020972
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUSTIVA efavirenz CAPSULE;ORAL 020972 NDA Bristol-Myers Squibb Pharma Company 0056-0470 0056-0470-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE (0056-0470-30)
SUSTIVA efavirenz CAPSULE;ORAL 020972 NDA Bristol-Myers Squibb Pharma Company 0056-0474 0056-0474-92 90 CAPSULE, GELATIN COATED in 1 BOTTLE (0056-0474-92)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Sep 17, 1998TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 6, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Oct 6, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Aug 14, 2018Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 020972

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-003 Sep 17, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-001 Sep 17, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-002 Sep 17, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-001 Sep 17, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-001 Sep 17, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-002 Sep 17, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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