Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075664
Company: NEPHRON
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 No
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.

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 075050 BAUSCH AND LOMB
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.5% BASE SOLUTION;INHALATION Prescription No AN 074543 HI TECH PHARMA
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.5% BASE SOLUTION;INHALATION Prescription No AN 075664 NEPHRON

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