Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076144
Company: INTL MEDICATED
Company: INTL MEDICATED
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/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 |
---|---|---|---|---|---|---|---|
01/26/2005 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/17/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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10/31/2017 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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04/27/2017 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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04/27/2017 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |