Drugs@FDA: FDA Approved Drug Products

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

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 AUROBINDO PHARMA LTD
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 PHARMA GLOBAL

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