Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075282
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CROMOLYN SODIUM CROMOLYN SODIUM 4% SOLUTION/DROPS;OPHTHALMIC Prescription AT 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
06/16/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75282ltr.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.

03/28/2002 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/07/2000 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/07/1999 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

CROMOLYN SODIUM

SOLUTION/DROPS;OPHTHALMIC; 4%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CROMOLYN SODIUM CROMOLYN SODIUM 4% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 074706 AKORN
CROMOLYN SODIUM CROMOLYN SODIUM 4% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 075282 SANDOZ INC

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