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Details for New Drug Application (NDA): 020933

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NDA 020933 describes VIRAMUNE, which is a drug marketed by Boehringer Ingelheim and is included in three NDAs. It is available from four suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the VIRAMUNE profile page.

The generic ingredient in VIRAMUNE is nevirapine. There are twenty drug master file entries for this compound. Nineteen suppliers are listed for this compound. There are eight tentative approvals for this compound. Additional details are available on the nevirapine profile page.

Summary for NDA: 020933

Tradename:
VIRAMUNE
Applicant:
Boehringer Ingelheim
Ingredient:
nevirapine
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020933

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIRAMUNE
nevirapine
SUSPENSION;ORAL 020933 NDA AUTHORIZED GENERIC Roxane Laboratories, Inc. 0054-0450 0054-0450-58 1 BOTTLE, PLASTIC in 1 CARTON (0054-0450-58) > 240 mL in 1 BOTTLE, PLASTIC
VIRAMUNE
nevirapine
SUSPENSION;ORAL 020933 NDA Boehringer Ingelheim Pharmaceuticals Inc. 0597-0047 0597-0047-24 1 BOTTLE, PLASTIC in 1 CARTON (0597-0047-24) > 240 mL in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength50MG/5ML
Approval Date:Sep 11, 1998TE:AARLD:Yes

Expired Orange Book Patents for NDA: 020933

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
VIRAMUNE
nevirapine
SUSPENSION;ORAL020933-001Sep 11, 19985,366,972*PED► subscribe
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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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