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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216160
Company: SOLARIS PHARMA CORP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESTRADIOL ESTRADIOL 0.06% (1.25GM/ACTIVATION) GEL, METERED;TRANSDERMAL 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
04/22/2024 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216160Orig1s000ltr.pdf

ESTRADIOL

GEL, METERED;TRANSDERMAL; 0.06% (1.25GM/ACTIVATION)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 0.06% (1.25GM/ACTIVATION) GEL, METERED;TRANSDERMAL Prescription No AB 217882 NOVITIUM PHARMA
ESTRADIOL ESTRADIOL 0.06% (1.25GM/ACTIVATION) GEL, METERED;TRANSDERMAL Prescription No AB 216160 SOLARIS PHARMA CORP
ESTROGEL ESTRADIOL 0.06% (1.25GM/ACTIVATION) GEL, METERED;TRANSDERMAL Prescription Yes AB 021166 ASCEND THERAPS US
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