Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204327

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PARICALCITOL (PARICALCITOL)
1MCG
Marketing Status: Prescription

Active Ingredient: PARICALCITOL
Proprietary Name: PARICALCITOL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1MCG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204327
Product Number: 001
Approval Date: Jan 13, 2016
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

PARICALCITOL (PARICALCITOL)
2MCG
Marketing Status: Prescription

Active Ingredient: PARICALCITOL
Proprietary Name: PARICALCITOL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 2MCG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204327
Product Number: 002
Approval Date: Jan 13, 2016
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

PARICALCITOL (PARICALCITOL)
4MCG
Marketing Status: Prescription

Active Ingredient: PARICALCITOL
Proprietary Name: PARICALCITOL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 4MCG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204327
Product Number: 003
Approval Date: Jan 13, 2016
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status:  Prescription
Patent and Exclusivity Information