Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211776
Company: CIPLA

Products on ANDA 211776

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIFLUPREDNATE	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211776

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/09/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211776Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 211776

DIFLUPREDNATE

EMULSION;OPHTHALMIC; 0.05%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIFLUPREDNATE	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	213774	ALEMBIC
DIFLUPREDNATE	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	211526	AMNEAL
DIFLUPREDNATE	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	219441	CAPLIN
DIFLUPREDNATE	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	211776	CIPLA
DIFLUPREDNATE	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	214894	DR REDDYS
DIFLUPREDNATE	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	207284	EPIC PHARMA LLC
DIFLUPREDNATE	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	212566	MYLAN LABS LTD
DIFLUPREDNATE	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	218191	UPSHER SMITH LABS
DUREZOL	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	Yes	AB	022212	SANDOZ