Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206329
Company: DR REDDYS LABS SA
Company: DR REDDYS LABS SA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.1MG BASE | TABLET;BUCCAL, SUBLINGUAL | Discontinued | None | No | No |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.2MG BASE | TABLET;BUCCAL, SUBLINGUAL | Discontinued | None | No | No |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.3MG BASE | TABLET;BUCCAL, SUBLINGUAL | Discontinued | None | No | No |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.4MG BASE | TABLET;BUCCAL, SUBLINGUAL | Discontinued | None | No | No |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.6MG BASE | TABLET;BUCCAL, SUBLINGUAL | Discontinued | None | No | No |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.8MG BASE | TABLET;BUCCAL, SUBLINGUAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/22/2022 | 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 |
|---|---|---|---|---|---|
| 12/08/2022 | SUPPL-1 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |