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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040728
Company: CHARTWELL RX

Products on ANDA 040728

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	50MG	TABLET;ORAL	Prescription	AA	No	No
BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	5MG	TABLET;ORAL	Prescription	AA	No	No
BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	10MG	TABLET;ORAL	Prescription	AA	No	No
BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	25MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040728

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/2007	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
05/08/2019	SUPPL-2	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 040728

BETHANECHOL CHLORIDE

TABLET;ORAL; 50MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	040855	AMNEAL PHARM
BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	040728	CHARTWELL RX
BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	040636	UPSHER SMITH LABS
DUVOID	BETHANECHOL CHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	085882	CHARTWELL RX

TABLET;ORAL; 5MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	5MG	TABLET;ORAL	Prescription	No	AA	040855	AMNEAL PHARM
BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	5MG	TABLET;ORAL	Prescription	No	AA	040728	CHARTWELL RX
BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	5MG	TABLET;ORAL	Prescription	No	AA	040633	UPSHER SMITH LABS

TABLET;ORAL; 10MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	040855	AMNEAL PHARM
BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	040728	CHARTWELL RX
BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	040634	UPSHER SMITH LABS
DUVOID	BETHANECHOL CHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	086262	CHARTWELL RX

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

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