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Last Updated: November 2, 2024

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-eight 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:RXDosage:TABLET;ORALStrength0.02MG;0.1MG
Approval Date:Jan 9, 2018TE:AB3RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jun 1, 2027Product Flag?Substance Flag?YDelist Request?
Patented Use:ADMINISTRATION OF FERROUS BISGLYCINATE TABLETS

Expired US Patents for NDA 208612

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 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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