NDC 35573-448

Leflunomide

Leflunomide

Leflunomide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Burel Pharmaceuticals, Llc. The primary component is Leflunomide.

Product ID35573-448_3ccf844c-7ef0-4dbe-9e27-bc3645903189
NDC35573-448
Product TypeHuman Prescription Drug
Proprietary NameLeflunomide
Generic NameLeflunomide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2022-01-03
Marketing CategoryANDA /
Application NumberANDA213497
Labeler NameBurel Pharmaceuticals, LLC
Substance NameLEFLUNOMIDE
Active Ingredient Strength20 mg/1
Pharm ClassesAntirheumatic Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 35573-448-30

30 TABLET, FILM COATED in 1 BOTTLE (35573-448-30)
Marketing Start Date2022-01-03
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Leflunomide" or generic name "Leflunomide"

NDCBrand NameGeneric Name
0955-1735Leflunomideleflunomide
0955-1737Leflunomideleflunomide
10702-277LeflunomideLeflunomide
10702-278LeflunomideLeflunomide
13811-677LeflunomideLeflunomide
13811-678LeflunomideLeflunomide
23155-043LeflunomideLeflunomide
68258-2992LeflunomideLeflunomide
23155-044LeflunomideLeflunomide
46708-437LeflunomideLeflunomide
46708-436LeflunomideLeflunomide
60505-2503LEFLUNOMIDELEFLUNOMIDE
60505-2502LEFLUNOMIDELEFLUNOMIDE
62332-062LeflunomideLeflunomide
62332-061LeflunomideLeflunomide
70710-1157leflunomideleflunomide
70710-1158leflunomideleflunomide
70771-1492leflunomideleflunomide
70771-1491leflunomideleflunomide
42291-420LEFLUNOMIDELEFLUNOMIDE
42291-421LEFLUNOMIDELEFLUNOMIDE
70748-130LeflunomideLeflunomide
70748-129LeflunomideLeflunomide
50268-477LEFLUNOMIDELEFLUNOMIDE
50268-478LEFLUNOMIDELEFLUNOMIDE
0088-2160Aravaleflunomide
0088-2161Aravaleflunomide
0088-2162Aravaleflunomide
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