Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075394
Company: WOCKHARDT EU OPERATN
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
11/22/1999 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75394ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/076394_amiodarone-hydrochloride_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/15/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/2001 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/30/2001 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/30/2001 SUPPL-1 Labeling

Label is not available on this site.

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