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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205878
Company: NOVEL LABS INC

Products on ANDA 205878

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205878

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/09/2015	ORIG-1	Approval		STANDARD	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205878Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/205878Orig1_Approval_Pkg.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/28/2021	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
02/14/2020	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205878

DICLOFENAC SODIUM

SOLUTION;TOPICAL; 1.5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION;TOPICAL	Prescription	No	AT	206116	AMNEAL PHARMS
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION;TOPICAL	Prescription	No	AT	206655	EPIC PHARMA LLC
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION;TOPICAL	Prescription	No	AT	204132	LUPIN
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION;TOPICAL	Prescription	No	AT	205878	NOVEL LABS INC
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION;TOPICAL	Prescription	No	AT	203818	SUN PHARMA CANADA
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION;TOPICAL	Prescription	No	AT	202852	WATSON LABS INC
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION;TOPICAL	Prescription	No	AT	206411	ZYDUS LIFESCIENCES

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