Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075358
Company: BAUSCH AND LOMB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION;INHALATION Discontinued None 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
03/29/2000 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-358_Albuterol%20Sulfate_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75358ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-358_Albuterol.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/21/2004 SUPPL-14 Labeling

Label is not available on this site.

05/14/2004 SUPPL-12 Labeling

Label is not available on this site.

07/23/2002 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

11/27/2001 SUPPL-5 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

09/21/2001 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/22/2001 SUPPL-3 Labeling

Label is not available on this site.

01/22/2001 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/22/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/29/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-358_Albuterol%20Sulfate_prntlbl.pdf

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