Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075502
Company: FOUGERA PHARMS
Company: FOUGERA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE | EQ 0.05% BASE;1% | CREAM;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 |
---|---|---|---|---|---|---|---|
06/05/2001 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75502ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-502_Clotrimazole.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/06/2020 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
07/06/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
09/11/2015 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
09/11/2015 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
06/26/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
CREAM;TOPICAL; EQ 0.05% BASE;1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE | EQ 0.05% BASE;1% | CREAM;TOPICAL | Prescription | No | AB | 076002 | ACTAVIS MID ATLANTIC |
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE | EQ 0.05% BASE;1% | CREAM;TOPICAL | Prescription | No | AB | 075502 | FOUGERA PHARMS |
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE | EQ 0.05% BASE;1% | CREAM;TOPICAL | Prescription | No | AB | 202894 | GLENMARK SPECLT |
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE | EQ 0.05% BASE;1% | CREAM;TOPICAL | Prescription | No | AB | 075673 | TARO |