Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040215
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM 10% 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
05/25/1999 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40215ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40216_Sulfacetamide%20Sodium%20Ophthalmic.pdf

SULFACETAMIDE SODIUM

SOLUTION/DROPS;OPHTHALMIC; 10%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BLEPH-10 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 080028 ALLERGAN
SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM 10% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 040215 AKORN
SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM 10% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 040066 BAUSCH AND LOMB
SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM 10% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 089560 SANDOZ INC

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