Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017972
Company: PHARMALUCENCE
Company: PHARMALUCENCE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OSTEOLITE | TECHNETIUM TC-99M MEDRONATE 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 |
|---|---|---|---|---|---|---|---|
| 12/16/1977 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/30/2002 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/10/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/04/1991 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/02/1989 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 01/07/1985 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/19/1984 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 04/30/1979 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/08/1980 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 05/07/1979 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 11/13/1978 | SUPPL-1 | Labeling |
Label is not available on this site. |