Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076067
Company: PADAGIS US
Company: PADAGIS US
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 | 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 |
---|---|---|---|---|---|---|---|
03/18/2002 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/76067_Mometasone Furoate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76067.ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76067.ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/076067_mometasone-furoate_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/23/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
08/29/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
04/05/2004 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
01/06/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/18/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/76067_Mometasone Furoate_Approv.pdf |
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 |