Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091412
Company: DR REDDYS
Company: DR REDDYS
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 |
---|---|---|---|---|---|---|---|
06/24/2014 | 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 |
---|---|---|---|---|---|
05/27/2015 | 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 | 207672 | AUROBINDO PHARMA LTD |
PARICALCITOL | PARICALCITOL | 1MCG | CAPSULE;ORAL | Prescription | No | AB | 202539 | BIONPHARMA |
PARICALCITOL | PARICALCITOL | 1MCG | CAPSULE;ORAL | Prescription | No | AB | 091412 | DR REDDYS |
PARICALCITOL | PARICALCITOL | 1MCG | CAPSULE;ORAL | Prescription | No | AB | 204948 | MARKSANS PHARMA |
PARICALCITOL | PARICALCITOL | 1MCG | CAPSULE;ORAL | Prescription | No | AB | 202124 | RISING |
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 | 207672 | AUROBINDO PHARMA LTD |
PARICALCITOL | PARICALCITOL | 2MCG | CAPSULE;ORAL | Prescription | No | AB | 202539 | BIONPHARMA |
PARICALCITOL | PARICALCITOL | 2MCG | CAPSULE;ORAL | Prescription | No | AB | 091412 | DR REDDYS |
PARICALCITOL | PARICALCITOL | 2MCG | CAPSULE;ORAL | Prescription | No | AB | 204948 | MARKSANS PHARMA |
PARICALCITOL | PARICALCITOL | 2MCG | CAPSULE;ORAL | Prescription | No | AB | 202124 | RISING |
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 | 207672 | AUROBINDO PHARMA LTD |
PARICALCITOL | PARICALCITOL | 4MCG | CAPSULE;ORAL | Prescription | No | AB | 202539 | BIONPHARMA |
PARICALCITOL | PARICALCITOL | 4MCG | CAPSULE;ORAL | Prescription | No | AB | 091412 | DR REDDYS |
PARICALCITOL | PARICALCITOL | 4MCG | CAPSULE;ORAL | Prescription | No | AB | 204948 | MARKSANS PHARMA |
PARICALCITOL | PARICALCITOL | 4MCG | CAPSULE;ORAL | Prescription | No | AB | 202124 | RISING |
PARICALCITOL | PARICALCITOL | 4MCG | CAPSULE;ORAL | Prescription | No | AB | 090829 | TEVA PHARMS USA |