U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204910
Company: DR REDDYS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PARICALCITOL PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
PARICALCITOL PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
PARICALCITOL PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription AP 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
08/17/2016 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204910Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/01/2024 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
03/01/2024 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

PARICALCITOL

SOLUTION;INTRAVENOUS; 0.002MG/ML (0.002MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PARICALCITOL PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 207174 ACCORD HLTHCARE
PARICALCITOL PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 206699 AMNEAL PHARMS CO
PARICALCITOL PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 204910 DR REDDYS
PARICALCITOL PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 205982 EUGIA PHARMA
PARICALCITOL PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 205917 HIKMA PHARMS
PARICALCITOL PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 091108 SANDOZ
ZEMPLAR PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 020819 ABBVIE

SOLUTION;INTRAVENOUS; 0.005MG/ML (0.005MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PARICALCITOL PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 207174 ACCORD HLTHCARE
PARICALCITOL PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 206699 AMNEAL PHARMS CO
PARICALCITOL PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 204910 DR REDDYS
PARICALCITOL PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 205982 EUGIA PHARMA
PARICALCITOL PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 205917 HIKMA PHARMS
PARICALCITOL PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 203897 RISING
PARICALCITOL PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 091108 SANDOZ
ZEMPLAR PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 020819 ABBVIE

SOLUTION;INTRAVENOUS; 0.01MG/2ML (0.005MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PARICALCITOL PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 207174 ACCORD HLTHCARE
PARICALCITOL PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 206699 AMNEAL PHARMS CO
PARICALCITOL PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 204910 DR REDDYS
PARICALCITOL PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 205982 EUGIA PHARMA
PARICALCITOL PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 205917 HIKMA PHARMS
PARICALCITOL PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 203897 RISING
PARICALCITOL PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 091108 SANDOZ
ZEMPLAR PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 020819 ABBVIE
Back to Top