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SULFACETAMIDE SODIUM

ANDA

SULFACETAMIDE SODIUM | A089560 | CHARTWELL RX SCIENCES LLC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Gordon Johnston Regulatory Consultants LLC FDA-2014-P-1576 · 6 docket documents Gordon Johnston Regulatory Consultants LLC filed this petition requesting that the FDA designate Sulfacetamide Sodium Ophthalmic Solution 10% manufactured by Alcon Pharmaceuticals (ANDA 89560) as a second reference listed drug in the Orange Book, arguing that the current reference listed drug formul	Other	2014-10-10	Open	Gordon Johnston Regulatory Consultants LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

NAPP CHEMICALS INCInactiveSULFACETAMIDE

DMF 44001981

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 10%

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Oct 18, 1988

No patent or exclusivity listings for this strength.