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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218384
Company: AMNEAL

Products on ANDA 218384

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SCOPOLAMINE	SCOPOLAMINE	1MG/72HR	SYSTEM;TRANSDERMAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218384

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/09/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218384

SCOPOLAMINE

SYSTEM;TRANSDERMAL; 1MG/72HR
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SCOPOLAMINE	SCOPOLAMINE	1MG/72HR	SYSTEM;TRANSDERMAL	Prescription	No	AB	208769	ACTAVIS LABS UT INC
SCOPOLAMINE	SCOPOLAMINE	1MG/72HR	SYSTEM;TRANSDERMAL	Prescription	No	AB	218384	AMNEAL
SCOPOLAMINE	SCOPOLAMINE	1MG/72HR	SYSTEM;TRANSDERMAL	Prescription	No	AB	203753	MYLAN TECHNOLOGIES
SCOPOLAMINE	SCOPOLAMINE	1MG/72HR	SYSTEM;TRANSDERMAL	Prescription	No	AB	078830	PADAGIS US
SCOPOLAMINE	SCOPOLAMINE	1MG/72HR	SYSTEM;TRANSDERMAL	Prescription	No	AB	215329	RHODES PHARMS
SCOPOLAMINE	SCOPOLAMINE	1MG/72HR	SYSTEM;TRANSDERMAL	Prescription	No	AB	212342	RICONPHARMA LLC
SCOPOLAMINE	SCOPOLAMINE	1MG/72HR	SYSTEM;TRANSDERMAL	Prescription	No	AB	217893	ZYDUS PHARMS
TRANSDERM SCOP	SCOPOLAMINE	1MG/72HR	SYSTEM;TRANSDERMAL	Prescription	Yes	AB	017874	BAXTER HLTHCARE CORP

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