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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 201152

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VIRAMUNE XR (NEVIRAPINE)
100MG
Marketing Status: Prescription
Active Ingredient: NEVIRAPINE
Proprietary Name: VIRAMUNE XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N201152
Product Number: 002
Approval Date: Nov 8, 2012
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VIRAMUNE XR (NEVIRAPINE)
400MG
Marketing Status: Prescription
Active Ingredient: NEVIRAPINE
Proprietary Name: VIRAMUNE XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 400MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N201152
Product Number: 001
Approval Date: Mar 25, 2011
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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