Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074706
Company: AKORN
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 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
04/29/1998 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/05/1999 SUPPL-1 Labeling

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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