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Generated: January 18, 2019

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Details for New Drug Application (NDA): 040066

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NDA 040066 describes SULFACETAMIDE SODIUM, which is a drug marketed by Fougera Pharms, Perrigo Co Tennessee, Taro, Akorn, Alcon Pharms Ltd, Bausch And Lomb, Pharmafair, and Sandoz Inc, and is included in twelve NDAs. It is available from seventeen suppliers. Additional details are available on the SULFACETAMIDE SODIUM profile page.

The generic ingredient in SULFACETAMIDE SODIUM is prednisolone sodium phosphate; sulfacetamide sodium. There are eighty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate; sulfacetamide sodium profile page.
Summary for 040066
Tradename:SULFACETAMIDE SODIUM
Applicant:Bausch And Lomb
Ingredient:sulfacetamide sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040066
Medical Subject Heading (MeSH) Categories for 040066
Suppliers and Packaging for NDA: 040066
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SULFACETAMIDE SODIUM sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 040066 ANDA Bausch & Lomb Incorporated 24208-670 24208-670-04 1 BOTTLE, DROPPER in 1 CARTON (24208-670-04) > 15 mL in 1 BOTTLE, DROPPER
SULFACETAMIDE SODIUM sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 040066 ANDA Lake Erie Medical DBA Quality Care Products LLC 49999-144 49999-144-15 15 mL in 1 BOTTLE, PLASTIC (49999-144-15)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength10%
Approval Date:Dec 28, 1994TE:ATRLD:No

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