Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078571
Company: GLENMARK PHARMS INC
Company: GLENMARK PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MOMETASONE FUROATE | MOMETASONE FUROATE | 0.1% | OINTMENT;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 |
---|---|---|---|---|---|---|---|
05/28/2008 | 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 |
---|---|---|---|---|---|
08/14/2024 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
08/14/2024 | SUPPL-9 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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08/18/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
MOMETASONE FUROATE
OINTMENT;TOPICAL; 0.1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MOMETASONE FUROATE | MOMETASONE FUROATE | 0.1% | OINTMENT;TOPICAL | Prescription | No | AB | 077401 | COSETTE |
MOMETASONE FUROATE | MOMETASONE FUROATE | 0.1% | OINTMENT;TOPICAL | Prescription | No | AB | 077061 | FOUGERA PHARMS |
MOMETASONE FUROATE | MOMETASONE FUROATE | 0.1% | OINTMENT;TOPICAL | Prescription | No | AB | 078571 | GLENMARK PHARMS INC |
MOMETASONE FUROATE | MOMETASONE FUROATE | 0.1% | OINTMENT;TOPICAL | Prescription | No | AB | 076067 | PADAGIS US |