Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075664
Company: NEPHRON

Products on ANDA 075664

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION;INHALATION	Prescription	AN	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075664

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/26/2001	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75664ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075664.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/29/2007	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075664

ALBUTEROL SULFATE

SOLUTION;INHALATION; EQ 0.5% BASE
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION;INHALATION	Prescription	No	AN	075664	NEPHRON
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION;INHALATION	Prescription	No	AN	074543	SENTISS