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DICLOFENAC SODIUM AND MISOPROSTOL

ANDA

DICLOFENAC SODIUM; MISOPROSTOL | A201089 | ACTAVIS LABORATORIES FL INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ARTHROTEC(TE code: AB)

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 11, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 50MG;0.2MG

0 patents0 exclusivities▴

TABLET, DELAYED RELEASE;ORAL | Approved: Jul 9, 2012

No patent or exclusivity listings for this strength.

#002 — 75MG;0.2MG

0 patents0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: Jul 9, 2012