Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070092
Company: IGI LABS INC
Company: IGI LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 160MG/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 |
|---|---|---|---|---|---|---|---|
| 10/23/1985 | 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 |
|---|---|---|---|---|---|
| 07/17/2002 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 10/03/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 06/02/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 09/30/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/30/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/03/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/03/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/31/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |