RecallHawk

XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL)

MYLAN TECHNOLOGIES

Summary

FDA approved XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) by MYLAN TECHNOLOGIES. ANDA (Generic) approval (Labeling) on 2022-04-29. FILM, EXTENDED RELEASE, TRANSDERMAL.

Details

Source

Drug Approval

External ID

ANDA200910-14

Action Date

2022-04-29

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

XULANE (generic: NORELGESTROMIN AND ETHINYL ESTRADIOL), FILM, EXTENDED RELEASE, TRANSDERMAL. Application: ANDA200910

Context & Analysis

MYLAN TECHNOLOGIES has 6 FDA actions in our database.

Frequently Asked Questions

How often does MYLAN TECHNOLOGIES have FDA actions?

MYLAN TECHNOLOGIES has 6 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 "ANDA200910-14" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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