Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075067
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CROMOLYN SODIUM CROMOLYN SODIUM 10MG/ML 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
07/19/1999 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75067ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74706ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/06/2005 SUPPL-6 Labeling

Label is not available on this site.

02/20/2002 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

04/03/2001 SUPPL-3 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/28/2000 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/28/2000 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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