Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210830
Company: AMNEAL

Products on ANDA 210830

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210830

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) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210830Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/210830Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/19/2023	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210830

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
ENILLORING	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING;VAGINAL	Prescription	No	AB	211157	XIROMED
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	DR REDDYS LABS SA
NUVARING	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING;VAGINAL	Prescription	Yes	AB	021187	ORGANON USA ORGANON