Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021846
Company: MICROBIX BIOSYSTEMS
Company: MICROBIX BIOSYSTEMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KINLYTIC | UROKINASE | 250,000 IU/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| KINLYTIC | UROKINASE | 9,000 IU/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| KINLYTIC | UROKINASE | 5,000 IU/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 01/16/1978 | ORIG-1 | Approval | N/A |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/18/2008 | SUPPL-101 | Supplement |
Label is not available on this site. |
||
| 10/30/2007 | SUPPL-99 | Supplement |
Label is not available on this site. |
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| 05/18/2007 | SUPPL-98 | Supplement |
Label is not available on this site. |
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| 06/30/1983 | SUPPL-28 | Supplement |
Label is not available on this site. |
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| 10/14/1983 | SUPPL-27 | Supplement |
Label is not available on this site. |
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| 01/22/1982 | SUPPL-22 | Supplement |
Label is not available on this site. |
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| 09/23/1981 | SUPPL-20 | Supplement |
Label is not available on this site. |
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| 04/20/1981 | SUPPL-17 | Supplement |
Label is not available on this site. |