Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065443
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;EQ 1% BASE | GEL;TOPICAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
08/11/2009 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/065443Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/01/2018 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
09/12/2014 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/29/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
GEL;TOPICAL; 5%;EQ 1% BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB | 209252 | GLENMARK PHARMS |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB | 065443 | MYLAN PHARMS INC |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB | 202440 | PADAGIS ISRAEL |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB | 208776 | TARO |