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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210830
Company: AMNEAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ELURYNG ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING;VAGINAL 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
12/11/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210830Orig1s000ltr.pdf

ELURYNG

RING;VAGINAL; 0.015MG/24HR;0.12MG/24HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ELURYNG ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING;VAGINAL Prescription No AB 210830 AMNEAL
ETHINYL ESTRADIOL; ETONOGESTREL ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING;VAGINAL Prescription No AB 204305 TEVA PHARMS USA INC
HALOETTE ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING;VAGINAL Prescription No AB 211328 MAYNE PHARMA
NUVARING ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING;VAGINAL Prescription Yes AB 021187 ORGANON USA ORGANON
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