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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074880
Company: NEPHRON

Products on ANDA 074880

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION;INHALATION	Prescription	AN	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074880

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/17/1997	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
03/28/2007	SUPPL-12	Labeling		Label is not available on this site.
06/06/2001	SUPPL-11	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
06/06/2001	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
08/17/2000	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/17/2000	SUPPL-7	Labeling		Label is not available on this site.
10/29/1999	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
07/21/1999	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/26/1998	SUPPL-2	Labeling		Label is not available on this site.
11/20/1997	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 074880

ALBUTEROL SULFATE

SOLUTION;INHALATION; EQ 0.083% 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 0.083% BASE	SOLUTION;INHALATION	Prescription	No	AN	206224	LUOXIN AUROVITAS
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION;INHALATION	Prescription	No	AN	074880	NEPHRON
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION;INHALATION	Prescription	No	AN	077839	RITEDOSE CORP
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION;INHALATION	Prescription	No	AN	207857	SUN PHARM

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