Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075358
Company: BAUSCH

Products on ANDA 075358

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075358

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.

Labels for ANDA 075358

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