Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064160
Company: FOUGERA PHARMS
Company: FOUGERA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | AB1 | 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 |
---|---|---|---|---|---|---|---|
01/28/2000 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/64160ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/064160_Clindamycin_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/02/2005 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
06/16/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
03/31/2003 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
12/16/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
07/27/2001 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CLINDAMYCIN PHOSPHATE
GEL;TOPICAL; EQ 1% BASE
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLEOCIN T | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | Yes | AB1 | 050615 | PFIZER |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB1 | 212466 | ALEMBIC |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB1 | 212438 | ENCUBE |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB1 | 064160 | FOUGERA PHARMS |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB1 | 214251 | GLENMARK PHARMS LTD |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB1 | 212104 | PADAGIS ISRAEL |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB1 | 211872 | SOLARIS PHARMA CORP |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB1 | 214052 | TARO |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB1 | 216587 | ZYDUS LIFESCIENCES |