Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075476
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARTEOLOL HYDROCHLORIDE CARTEOLOL HYDROCHLORIDE 1% SOLUTION/DROPS;OPHTHALMIC Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/03/2000 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75476ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75476ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/23/2002 SUPPL-5 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/01/2002 SUPPL-4 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/22/2002 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/01/2001 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/01/2001 SUPPL-1 Labeling

Label is not available on this site.

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