Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 216786
Company: AACE PHARMS

Products on ANDA 216786

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216786

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/01/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216786

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	216786	AACE PHARMS
METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET;ORAL	Prescription	No	AA	200602	BAYSHORE PHARMS LLC
METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET;ORAL	Prescription	No	AA	040642	BRECKENRIDGE PHARM

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	216786	AACE PHARMS
METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE	5MG	TABLET;ORAL	Prescription	No	AA	200602	BAYSHORE PHARMS LLC
METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE	5MG	TABLET;ORAL	Prescription	No	AA	040642	BRECKENRIDGE PHARM