Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077838
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE | BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE | 3MG/ML;EQ 3MG BASE/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
01/17/2023 | ORIG-1 | Approval |
Label is not available on this site. |
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
INJECTABLE;INJECTION; 3MG/ML;EQ 3MG BASE/ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE | BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE | 3MG/ML;EQ 3MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AB | 090747 | AM REGENT |
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE | BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE | 3MG/ML;EQ 3MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AB | 077838 | HIKMA |
CELESTONE SOLUSPAN | BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE | 3MG/ML;EQ 3MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AB | 014602 | ORGANON |