Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078066
Company: LONG GROVE PHARMS
Company: LONG GROVE PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CALCITRIOL | CALCITRIOL | 0.001MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
CALCITRIOL | CALCITRIOL | 0.002MG/ML | INJECTABLE;INJECTION | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
01/29/2008 | 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 |
---|---|---|---|---|---|
05/06/2013 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
CALCITRIOL
INJECTABLE;INJECTION; 0.001MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CALCITRIOL | CALCITRIOL | 0.001MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211030 | GLAND PHARMA LTD |
CALCITRIOL | CALCITRIOL | 0.001MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078066 | LONG GROVE PHARMS |