Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076012
Company: INTL MEDICATED
Company: INTL MEDICATED
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Discontinued | None | No | No |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Discontinued | None | No | No |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.75% | 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 |
---|---|---|---|---|---|---|---|
01/09/2002 | ORIG-1 | Approval |
Label is not available on this site. |