Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079061
Company: GLENMARK PHARMS LTD
Company: GLENMARK PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALCLOMETASONE DIPROPIONATE | ALCLOMETASONE DIPROPIONATE | 0.05% | 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 |
---|---|---|---|---|---|---|---|
06/23/2009 | 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 |
---|---|---|---|---|---|
04/17/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
ALCLOMETASONE DIPROPIONATE
CREAM;TOPICAL; 0.05%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALCLOMETASONE DIPROPIONATE | ALCLOMETASONE DIPROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB | 076973 | FOUGERA PHARMS |
ALCLOMETASONE DIPROPIONATE | ALCLOMETASONE DIPROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB | 079061 | GLENMARK PHARMS LTD |
ALCLOMETASONE DIPROPIONATE | ALCLOMETASONE DIPROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB | 076587 | TARO |