Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202894
Company: GLENMARK SPECLT
Company: GLENMARK SPECLT
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 |
---|---|---|---|---|---|---|---|
10/30/2015 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/29/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
05/29/2020 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
12/13/2016 | SUPPL-3 | Labeling-Package Insert |
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 |