Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021435
Company: DR REDDYS LABS INC
Company: DR REDDYS LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMVAZ | AMLODIPINE MALEATE | 2.5MG | TABLET;ORAL | Discontinued | None | No | No |
| AMVAZ | AMLODIPINE MALEATE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| AMVAZ | AMLODIPINE MALEATE | 10MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 10/31/2003 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21435ltr.pdf |