cursions permitted to 15-30°C (59-86°F). (See USP Controlled Room Temperature).
Mfd for and Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202
© 2017 Symbiomix Therapeutics, LLC (A Lupin Company). All Rights Reserved
Solosec™ is a trademark of Symbiomix Therapeutics, LLC (A Lupin Company)
Revised October 2017
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INGREDIENTS AND APPEARANCE
SOLOSEC
secnidazole granule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27437-051
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
secnidazole (UNII: R3459K699K) (secnidazole - UNII:R3459K699K) secnidazole 2 g in 4.8 g
Inactive Ingredients
Ingredient Name
Strength
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) (UNII: P2OM2Q86BI)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:27437-051-01 1 in 1 BOX, UNIT-DOSE 10/30/2017
1
2 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
NDA NDA209363 10/30/2017
Labeler - LUPIN PHARMA (965791259)
Registrant - LUPIN PHARMA (965791259)
Establishment
Name
Address
ID/FEI
Business Operations
Catalent Pharma Solutions 825745131 manufacture(27437-051)
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=551e43d5-f700-4d6e-8029-026f8a8932ff
