Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 018263
Company: PHARMALUCENCE
Company: PHARMALUCENCE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MICROLITE | TECHNETIUM TC-99M ALBUMIN COLLOID KIT | N/A | 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 |
---|---|---|---|---|---|---|---|
03/25/1983 | 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 |
---|---|---|---|---|---|
04/26/1989 | SUPPL-10 | Supplement |
Label is not available on this site. |
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05/02/1989 | SUPPL-9 | Supplement |
Label is not available on this site. |
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09/24/1987 | SUPPL-8 | Supplement |
Label is not available on this site. |
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03/17/1989 | SUPPL-7 | Supplement |
Label is not available on this site. |
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05/06/1986 | SUPPL-5 | Supplement |
Label is not available on this site. |
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08/26/1987 | SUPPL-4 | Supplement |
Label is not available on this site. |
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07/18/1984 | SUPPL-2 | Supplement |
Label is not available on this site. |
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05/31/1983 | SUPPL-1 | Supplement |
Label is not available on this site. |