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MISOPROSTOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVEL LABS INC · Approved 2012-07-25

Drug application

FDA Application #

ANDA091667

Application type

Abbreviated New Drug Application (Generic)

Brand name

MISOPROSTOL

Generic name

MISOPROSTOL

Active ingredients

MISOPROSTOL

Dosage form

TABLET

Route

ORAL

Marketing status

Discontinued

Sponsor

NOVEL LABS INC

Manufacturer

Novel Laboratories, Inc.

First approval

2012-07-25

Source

Authoritative

Drugs@FDA application overview

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