← FDA Drug Approvals (Drugs@FDA)

OPCICON ONE-STEP

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARM · Approved 2014-09-11

Drug application

FDA Application #

ANDA202635

Application type

Abbreviated New Drug Application (Generic)

Brand name

OPCICON ONE-STEP

Generic name

LEVONORGESTREL

Active ingredients

LEVONORGESTREL

Dosage form

TABLET

Route

ORAL

Marketing status

Over-the-counter

Sponsor

SUN PHARM

Manufacturer

Cardinal Health 110, LLC. DBA Leader

First approval

2014-09-11

Source

Authoritative

Drugs@FDA application overview

Machine

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