Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090638
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEDOCROMIL SODIUM NEDOCROMIL SODIUM 2% 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
08/22/2012 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090638Orig1s000ltr.pdf

NEDOCROMIL SODIUM

SOLUTION/DROPS;OPHTHALMIC; 2%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALOCRIL NEDOCROMIL SODIUM 2% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 021009 ALLERGAN
NEDOCROMIL SODIUM NEDOCROMIL SODIUM 2% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 090638 AKORN

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