Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 063304
Company: XTTRIUM LABS INC
Company: XTTRIUM LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SOLUTION;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
07/15/1997 | 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 |
---|---|---|---|---|---|
05/15/2001 | SUPPL-4 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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05/15/2001 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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04/03/2000 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |