Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018014
Company: INTL MEDICATION
Company: INTL MEDICATION
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 40MG/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 |
---|---|---|---|---|---|---|---|
05/19/1981 | 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 |
---|---|---|---|---|---|
09/19/1995 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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06/17/1994 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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01/14/1998 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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10/29/1993 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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12/17/1992 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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08/11/1992 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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10/23/1991 | SUPPL-18 | Labeling |
Label is not available on this site. |
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06/12/1991 | SUPPL-17 | Labeling |
Label is not available on this site. |
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02/21/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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05/20/1986 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |