Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214737
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 1.4MG BASE;EQ 0.36MG BASE | TABLET;SUBLINGUAL | None (Tentative Approval) | None | No | No |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 5.7MG BASE;EQ 1.4MG BASE | TABLET;SUBLINGUAL | None (Tentative Approval) | None | No | No |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8.6MG BASE;EQ 2.1MG BASE | TABLET;SUBLINGUAL | None (Tentative Approval) | None | No | No |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 11.4MG BASE;EQ 2.9MG BASE | TABLET;SUBLINGUAL | None (Tentative Approval) | None | No | No |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2.9MG BASE;EQ 0.71MG BASE | TABLET;SUBLINGUAL | None (Tentative Approval) | None | No | No |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 0.7MG BASE;EQ 0.18MG BASE | TABLET;SUBLINGUAL | None (Tentative Approval) | 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 |
---|---|---|---|---|---|---|---|
08/11/2023 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |