Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200602
Company: UNICHEM

Products on ANDA 200602

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET;ORAL	Prescription	AA	No	No
METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE	5MG	TABLET;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200602

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/24/2012	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/23/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200602

METHSCOPOLAMINE BROMIDE

TABLET;ORAL; 2.5MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET;ORAL	Prescription	No	AA	040642	BRECKENRIDGE PHARM
METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET;ORAL	Prescription	No	AA	216786	NE RX PHARMA
METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET;ORAL	Prescription	No	AA	200602	UNICHEM

TABLET;ORAL; 5MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE	5MG	TABLET;ORAL	Prescription	No	AA	040642	BRECKENRIDGE PHARM
METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE	5MG	TABLET;ORAL	Prescription	No	AA	216786	NE RX PHARMA
METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE	5MG	TABLET;ORAL	Prescription	No	AA	200602	UNICHEM