Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213897
Company: AJANTA PHARMA LTD
Company: AJANTA PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE;ORAL | Discontinued | None | No | No |
| CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE;ORAL | Discontinued | None | No | No |
| CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/02/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |