Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206953
Company: DR REDDYS LABS SA
Company: DR REDDYS LABS SA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | TABLET;SUBLINGUAL | Discontinued | None | No | No |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 07/17/2020 | 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 |
|---|---|---|---|---|---|
| 12/16/2022 | SUPPL-11 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 06/17/2022 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/03/2022 | SUPPL-9 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 06/17/2022 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/14/2022 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/04/2021 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |