Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075673
Company: TARO
Company: TARO
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 | 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 |
---|---|---|---|---|---|---|---|
05/29/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75673ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/06/2020 | SUPPL-21 | 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. |
||
07/06/2020 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
01/29/2009 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
06/23/2004 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
06/23/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
04/11/2002 | 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 |