Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086263
Company: CHARTWELL RX

Products on ANDA 086263

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DUVOID	BETHANECHOL CHLORIDE	25MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 086263

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/1978	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/28/2004	SUPPL-22	Labeling		Label is not available on this site.
07/11/1996	SUPPL-15	Labeling		Label is not available on this site.
12/28/1989	SUPPL-14	Labeling		Label is not available on this site.
11/15/1988	SUPPL-13	Labeling		Label is not available on this site.
09/29/1983	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 086263

DUVOID

TABLET;ORAL; 25MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	040855	AMNEAL PHARM
BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	040728	CHARTWELL RX
BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	040635	UPSHER SMITH LABS
DUVOID	BETHANECHOL CHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	086263	CHARTWELL RX