Drugs@FDA: FDA-Approved Drugs
Company: PADAGIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB;TOPICAL | Prescription | AT | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/25/2000 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65049ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/065049_clindamycin_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/03/2020 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
04/03/2020 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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07/15/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
01/14/2014 | SUPPL-11 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
10/19/2010 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
11/30/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
06/27/2002 | SUPPL-5 | Labeling |
Label is not available on this site. |
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06/27/2002 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/21/2001 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
11/21/2001 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
11/21/2001 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
CLINDAMYCIN PHOSPHATE
SWAB;TOPICAL; EQ 1% BASE
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB;TOPICAL | Prescription | No | AT | 065513 | EPIC PHARMA LLC |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB;TOPICAL | Prescription | No | AT | 065049 | PADAGIS US |
CLINDETS | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB;TOPICAL | Prescription | No | AT | 064136 | PADAGIS US |