BALCOLTRA (LEVONORGESTREL AND ETHINYL ESTRADIOL)
Summary
FDA approved BALCOLTRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) by AVION PHARMS. NDA (New Drug) approval (Labeling) on 2022-04-29. TABLET, ORAL.
Details
Source
Drug Approval
External ID
NDA208612-5
Action Date
2022-04-29
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
BALCOLTRA (generic: LEVONORGESTREL AND ETHINYL ESTRADIOL), TABLET, ORAL. Application: NDA208612
Company
Context & Analysis
AVION PHARMS has 3 FDA actions in our database.
Frequently Asked Questions
How often does AVION PHARMS have FDA actions?
AVION PHARMS has 3 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA208612-5" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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