Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212363
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALLOPURINOL SODIUM | ALLOPURINOL SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
01/26/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/08/2022 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
ALLOPURINOL SODIUM
INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALLOPURINOL SODIUM | ALLOPURINOL SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 212363 | GLAND PHARMA LTD |
ALLOPURINOL SODIUM | ALLOPURINOL SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 076870 | HIKMA |
ALOPRIM | ALLOPURINOL SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 020298 | MYLAN |