Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017321
Company: PHARMALUCENCE
Company: PHARMALUCENCE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM PERTECHNETATE TC 99M | TECHNETIUM TC-99M SODIUM PERTECHNETATE | 12mCi/ML | SOLUTION;INJECTION, ORAL | Discontinued | None | No | No |
SODIUM PERTECHNETATE TC 99M | TECHNETIUM TC-99M SODIUM PERTECHNETATE | 24mCi/ML | SOLUTION;INJECTION, ORAL | Discontinued | None | No | No |
SODIUM PERTECHNETATE TC 99M | TECHNETIUM TC-99M SODIUM PERTECHNETATE | 48mCi/ML | SOLUTION;INJECTION, ORAL | 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 |
---|---|---|---|---|---|---|---|
10/20/1976 | 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 |
---|---|---|---|---|---|
01/27/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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07/27/1981 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |