Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075630
Company: MEDIMETRIKS PHARMS

Products on ANDA 075630

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BETAXOLOL HYDROCHLORIDE	BETAXOLOL HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075630

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/12/2001	ORIG-1	Approval			Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75630ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75630ta.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/06/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
11/27/2001	SUPPL-1	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.

Therapeutic Equivalents for ANDA 075630

BETAXOLOL HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETAXOLOL HYDROCHLORIDE	BETAXOLOL HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	078694	ACELLA
BETAXOLOL HYDROCHLORIDE	BETAXOLOL HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	075630	MEDIMETRIKS PHARMS
BETOPTIC	BETAXOLOL HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	019270	SANDOZ