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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 208612

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NDA 208612 describes BALCOLTRA, which is a drug marketed by Avion Pharms and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the BALCOLTRA profile page.

The generic ingredient in BALCOLTRA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for 208612

Tradename:	BALCOLTRA
Applicant:	Avion Pharms
Ingredient:	ethinyl estradiol; levonorgestrel
Patents:	1

Suppliers and Packaging for NDA: 208612

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BALCOLTRA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	208612	NDA	Acella Pharmaceuticals	42192-623	42192-623-03	3 BLISTER PACK in 1 CARTON (42192-623-03) / 1 KIT in 1 BLISTER PACK
BALCOLTRA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	208612	NDA	Acella Pharmaceuticals	42192-623	42192-623-28	1 BLISTER PACK in 1 CARTON (42192-623-28) / 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.02MG;0.1MG
Approval Date:	Jan 9, 2018	TE:	AB3	RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Jun 1, 2027	Product Flag?		Substance Flag?	Y	Delist Request?
Patented Use:	ADMINISTRATION OF FERROUS BISGLYCINATE TABLETS

Expired US Patents for NDA 208612

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Avion Pharms	BALCOLTRA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	208612-001	Jan 9, 2018	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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