Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209115

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RUBRACA (RUCAPARIB CAMSYLATE)
EQ 200MG BASE
Marketing Status: Prescription

Active Ingredient: RUCAPARIB CAMSYLATE
Proprietary Name: RUBRACA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209115
Product Number: 001
Approval Date: Dec 19, 2016
Applicant Holder Full Name: ZR PHARMA AND GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information

RUBRACA (RUCAPARIB CAMSYLATE)
EQ 250MG BASE
Marketing Status: Prescription

Active Ingredient: RUCAPARIB CAMSYLATE
Proprietary Name: RUBRACA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 250MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209115
Product Number: 003
Approval Date: May 1, 2017
Applicant Holder Full Name: ZR PHARMA AND GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information

RUBRACA (RUCAPARIB CAMSYLATE)
EQ 300MG BASE
Marketing Status: Prescription

Active Ingredient: RUCAPARIB CAMSYLATE
Proprietary Name: RUBRACA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 300MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209115
Product Number: 002
Approval Date: Dec 19, 2016
Applicant Holder Full Name: ZR PHARMA AND GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information