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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201089
Company: ACTAVIS LABS FL INC

Products on ANDA 201089

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No
DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201089

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/09/2012	ORIG-1	Approval	Not Applicable		Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201089Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/201089Orig1s000BioeqR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/16/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/16/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201089

DICLOFENAC SODIUM AND MISOPROSTOL

TABLET, DELAYED RELEASE;ORAL; 50MG;0.2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARTHROTEC	DICLOFENAC SODIUM; MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	020607	PFIZER
DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	201089	ACTAVIS LABS FL INC
DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	203995	AMNEAL PHARMS
DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	204355	MICRO LABS
DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	200158	SANDOZ
DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	205143	YUNG SHIN PHARM

TABLET, DELAYED RELEASE;ORAL; 75MG;0.2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARTHROTEC	DICLOFENAC SODIUM; MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	020607	PFIZER
DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	201089	ACTAVIS LABS FL INC
DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	203995	AMNEAL PHARMS
DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	204355	MICRO LABS
DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	200158	SANDOZ
DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	205143	YUNG SHIN PHARM

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