Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076350
Company: BTG INTL

Products on ANDA 076350

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THYROSAFE	POTASSIUM IODIDE	65MG	TABLET;ORAL	Over-the-counter	None	No	Yes
THYROSAFE	POTASSIUM IODIDE	130MG	TABLET;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076350

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/10/2002	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
02/13/2004	SUPPL-4	Labeling		Label is not available on this site.
05/21/2003	SUPPL-2	Labeling		Label is not available on this site.
04/30/2003	SUPPL-1	Labeling		Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

THYROSAFE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 65MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
IOSAT	POTASSIUM IODIDE	65MG	TABLET;ORAL	Over-the-counter	Yes	018664	ANBEX
THYROSAFE	POTASSIUM IODIDE	65MG	TABLET;ORAL	Over-the-counter	No	076350	BTG INTL

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 130MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
IOSAT	POTASSIUM IODIDE	130MG	TABLET;ORAL	Over-the-counter	Yes	018664	ANBEX
THYROSAFE	POTASSIUM IODIDE	130MG	TABLET;ORAL	Over-the-counter	No	076350	BTG INTL