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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208612
Company: AVION PHARMS

Products on NDA 208612

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BALCOLTRA	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL	Prescription	AB3	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208612

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/09/2018	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208612s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208612Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208612Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208612s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208612Orig1s005ltr.pdf

Labels for NDA 208612

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208612s005lbl.pdf
01/09/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208612s000lbl.pdf

Therapeutic Equivalents for NDA 208612

BALCOLTRA

TABLET;ORAL; 0.02MG;0.1MG
TE Code = AB3

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BALCOLTRA	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL	Prescription	Yes	AB3	208612	AVION PHARMS
LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL	Prescription	No	AB3	214640	XIROMED
MINZOYA	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL	Prescription	No	AB3	217087	LUPIN LTD

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