An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075541
Company: EPIC PHARMA

Products on ANDA 075541

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BETAXOLOL HYDROCHLORIDE	BETAXOLOL HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	AB	No	No
BETAXOLOL HYDROCHLORIDE	BETAXOLOL HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075541

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/22/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75441ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2014	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075541Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/075541Orig1s010ltr.pdf
11/02/1999	SUPPL-2	Labeling		Label is not available on this site.
11/02/1999	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 075541

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2014	SUPPL-10	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075541Orig1s010lbl.pdf
12/19/2014	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075541Orig1s010lbl.pdf

Therapeutic Equivalents for ANDA 075541

BETAXOLOL HYDROCHLORIDE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETAXOLOL HYDROCHLORIDE	BETAXOLOL HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	075541	EPIC PHARMA
BETAXOLOL HYDROCHLORIDE	BETAXOLOL HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	078962	KVK TECH

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETAXOLOL HYDROCHLORIDE	BETAXOLOL HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	075541	EPIC PHARMA
BETAXOLOL HYDROCHLORIDE	BETAXOLOL HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	078962	KVK TECH

Top