FDA.reportPublic FDA data

Application 203458

Type
ANDA
Sponsor
UNICHEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METRONIDAZOLEMETRONIDAZOLETABLET;ORAL250MGNoNo
002METRONIDAZOLEMETRONIDAZOLETABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
12634-172MetronidazoleMetronidazoleApotheca Inc.ANDACurrent
29300-226MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-226MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-226MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-226MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-226MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-226MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-227MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-227MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-227MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-227MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-227MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-227MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
43063-719MetronidazoleMetronidazolePD-Rx Pharmaceuticals, InANDACurrent
43063-719MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-719MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-719MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-719MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-719MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-719MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-738MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-738MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-738MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-738MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-738MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-738MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-717MetronidazoleMetronidazolemedsource pharmaceuticalsANDACurrent
50090-0201MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0201MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0201MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0201MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0211MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0211MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0211MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0211MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0212MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0212MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0212MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0212MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0213MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0213MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0213MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0213MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0214MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0214MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-4392MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50436-0227MetronidazoleMetronidazoleUnit Dose ServicesANDACurrent
53002-2470MetronidazoleMetronidazoleRPK Pharmaceuticals, Inc.ANDACurrent
53002-2470MetronidazoleMetronidazoleRPK Pharmaceuticals, Inc.ANDACurrent
54348-740MetronidazoleMETRONIDAZOLEPharmPak, Inc.ANDACurrent
54348-740MetronidazoleMETRONIDAZOLEPharmPak, Inc.ANDACurrent
54348-745MetronidazoleMETRONIDAZOLEPharmPak, Inc.ANDACurrent
54348-745MetronidazoleMETRONIDAZOLEPharmPak, Inc.ANDACurrent
55700-298MetronidazoleMetronidazoleLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-298MetronidazoleMetronidazoleLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-298MetronidazoleMetronidazoleLake Erie Medical DBA Quality Care Products LLCANDACurrent
58118-0527MetronidazoleMetronidazoleClinical Solutions Wholesale, LLCANDACurrent
58118-0527MetronidazoleMetronidazoleClinical Solutions Wholesale, LLCANDACurrent
58118-0527MetronidazoleMetronidazoleClinical Solutions Wholesale, LLCANDACurrent
60760-336MetronidazoleMetronidazoleSt. Mary's Medical Park PharmacyANDACurrent
60760-336MetronidazoleMetronidazoleSt. Mary's Medical Park PharmacyANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDIRECT RXANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDIRECT RXANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDirect_RxANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDirect_RxANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDIRECT RXANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDIRECT RXANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDirect_RxANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDirect_RxANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDirect_RxANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDirect_RxANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDirect_RxANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDIRECT RXANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDIRECT RXANDACurrent
61919-499METRONIDAZOLEMETRONIDAZOLEDirect_RxANDACurrent
61919-499METRONIDAZOLEMETRONIDAZOLEDIRECT RXANDACurrent
61919-499METRONIDAZOLEMETRONIDAZOLEDIRECT RXANDACurrent
61919-499METRONIDAZOLEMETRONIDAZOLEDirect_RxANDACurrent
61919-499METRONIDAZOLEMETRONIDAZOLEDirect_RxANDACurrent
63187-827MetronidazoleMetronidazoleProficient Rx LPANDACurrent