Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214512
Company: NOVITIUM PHARMA
Company: NOVITIUM PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE/75ML | SOLUTION;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
05/11/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ALENDRONATE SODIUM
SOLUTION;ORAL; EQ 70MG BASE/75ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE/75ML | SOLUTION;ORAL | Prescription | No | AA | 090520 | HIKMA |
ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE/75ML | SOLUTION;ORAL | Prescription | No | AA | 214512 | NOVITIUM PHARMA |