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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216348
Company: AMNEAL

Products on ANDA 216348

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOROMETHOLONE	FLUOROMETHOLONE	0.1%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216348

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/09/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216348

FLUOROMETHOLONE

SUSPENSION/DROPS;OPHTHALMIC; 0.1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOROMETHOLONE	FLUOROMETHOLONE	0.1%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	No	AB	216348	AMNEAL
FML	FLUOROMETHOLONE	0.1%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	Yes	AB	016851	ABBVIE

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