Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202539
Company: BIONPHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PARICALCITOL PARICALCITOL 1MCG CAPSULE;ORAL Prescription AB No No
PARICALCITOL PARICALCITOL 2MCG CAPSULE;ORAL Prescription AB No No
PARICALCITOL PARICALCITOL 4MCG CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/27/2014 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/30/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

PARICALCITOL

CAPSULE;ORAL; 1MCG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PARICALCITOL PARICALCITOL 1MCG CAPSULE;ORAL Prescription No AB 204327 AMNEAL PHARMS
PARICALCITOL PARICALCITOL 1MCG CAPSULE;ORAL Prescription No AB 202124 ANDA REPOSITORY
PARICALCITOL PARICALCITOL 1MCG CAPSULE;ORAL Prescription No AB 207672 AUROBINDO PHARMA LTD
PARICALCITOL PARICALCITOL 1MCG CAPSULE;ORAL Prescription No AB 202539 BIONPHARMA INC
PARICALCITOL PARICALCITOL 1MCG CAPSULE;ORAL Prescription No AB 091412 DR REDDYS LABS LTD
PARICALCITOL PARICALCITOL 1MCG CAPSULE;ORAL Prescription No AB 206710 LOTUS PHARM CO LTD
PARICALCITOL PARICALCITOL 1MCG CAPSULE;ORAL Prescription No AB 204948 MARKSANS PHARMA
PARICALCITOL PARICALCITOL 1MCG CAPSULE;ORAL Prescription No AB 090829 TEVA PHARMS USA
ZEMPLAR PARICALCITOL 1MCG CAPSULE;ORAL Prescription Yes AB 021606 ABBVIE

CAPSULE;ORAL; 2MCG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PARICALCITOL PARICALCITOL 2MCG CAPSULE;ORAL Prescription No AB 204327 AMNEAL PHARMS
PARICALCITOL PARICALCITOL 2MCG CAPSULE;ORAL Prescription No AB 202124 ANDA REPOSITORY
PARICALCITOL PARICALCITOL 2MCG CAPSULE;ORAL Prescription No AB 207672 AUROBINDO PHARMA LTD
PARICALCITOL PARICALCITOL 2MCG CAPSULE;ORAL Prescription No AB 202539 BIONPHARMA INC
PARICALCITOL PARICALCITOL 2MCG CAPSULE;ORAL Prescription No AB 091412 DR REDDYS LABS LTD
PARICALCITOL PARICALCITOL 2MCG CAPSULE;ORAL Prescription No AB 206710 LOTUS PHARM CO LTD
PARICALCITOL PARICALCITOL 2MCG CAPSULE;ORAL Prescription No AB 204948 MARKSANS PHARMA
PARICALCITOL PARICALCITOL 2MCG CAPSULE;ORAL Prescription No AB 090829 TEVA PHARMS USA
ZEMPLAR PARICALCITOL 2MCG CAPSULE;ORAL Prescription Yes AB 021606 ABBVIE

CAPSULE;ORAL; 4MCG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PARICALCITOL PARICALCITOL 4MCG CAPSULE;ORAL Prescription No AB 204327 AMNEAL PHARMS
PARICALCITOL PARICALCITOL 4MCG CAPSULE;ORAL Prescription No AB 202124 ANDA REPOSITORY
PARICALCITOL PARICALCITOL 4MCG CAPSULE;ORAL Prescription No AB 207672 AUROBINDO PHARMA LTD
PARICALCITOL PARICALCITOL 4MCG CAPSULE;ORAL Prescription No AB 202539 BIONPHARMA INC
PARICALCITOL PARICALCITOL 4MCG CAPSULE;ORAL Prescription No AB 091412 DR REDDYS LABS LTD
PARICALCITOL PARICALCITOL 4MCG CAPSULE;ORAL Prescription No AB 206710 LOTUS PHARM CO LTD
PARICALCITOL PARICALCITOL 4MCG CAPSULE;ORAL Prescription No AB 204948 MARKSANS PHARMA
PARICALCITOL PARICALCITOL 4MCG CAPSULE;ORAL Prescription No AB 090829 TEVA PHARMS USA

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