Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207952
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOGILIA ULIPRISTAL ACETATE 30MG TABLET;ORAL 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
02/13/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207952Orig1s000ltr.pdf

LOGILIA

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ELLA ULIPRISTAL ACETATE 30MG TABLET;ORAL Prescription Yes AB 022474 LAB HRA PHARMA
LOGILIA ULIPRISTAL ACETATE 30MG TABLET;ORAL Prescription No AB 207952 TEVA PHARMS USA

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