Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 207174
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
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 |
---|---|---|---|---|---|---|---|
02/04/2016 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207174s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207174Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207174Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207174Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/17/2019 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207174s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207174Orig1s006ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/17/2019 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207174s006lbl.pdf | |
02/04/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207174s000lbl.pdf |
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 |