Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076730
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALCLOMETASONE DIPROPIONATE | ALCLOMETASONE DIPROPIONATE | 0.05% | OINTMENT;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 |
---|---|---|---|---|---|---|---|
07/29/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76730ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/26/2011 | SUPPL-7 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
ALCLOMETASONE DIPROPIONATE
OINTMENT;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% | OINTMENT;TOPICAL | Prescription | No | AB | 076884 | FOUGERA PHARMS |
ALCLOMETASONE DIPROPIONATE | ALCLOMETASONE DIPROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 079227 | GLENMARK PHARMS LTD |
ALCLOMETASONE DIPROPIONATE | ALCLOMETASONE DIPROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 076730 | TARO |