Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070298
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NALOXONE | NALOXONE HYDROCHLORIDE | 0.4MG/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 |
|---|---|---|---|---|---|---|---|
| 10/22/1985 | 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 |
|---|---|---|---|---|---|
| 11/04/1999 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/11/1999 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/11/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/26/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/26/1993 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 01/16/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 01/16/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 12/19/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/29/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/29/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |