Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074471
Company: DR REDDYS
Company: DR REDDYS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 03/19/1998 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74471.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2023 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/09/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/23/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |