FDA.reportPublic FDA data

Application 077666

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIRTAZAPINEMIRTAZAPINETABLET;ORAL15MGNoNo
002MIRTAZAPINEMIRTAZAPINETABLET;ORAL30MGNoNo
003MIRTAZAPINEMIRTAZAPINETABLET;ORAL45MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6519MirtazapineMirtazapineMajor PharmaceuticalsANDACurrent
0904-6519MirtazapineMirtazapineMajor PharmaceuticalsANDACurrent
0904-6519MirtazapineMirtazapineMajor PharmaceuticalsANDACurrent
0904-6519MirtazapineMirtazapineMajor PharmaceuticalsANDACurrent
0904-6519MirtazapineMirtazapineMajor PharmaceuticalsANDACurrent
0904-6519MirtazapineMirtazapineMajor PharmaceuticalsANDACurrent
43353-378MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
45865-361MirtazapineMirtazapineMedsource PharmaceuitcalsANDACurrent
50090-4222MirtazapineMirtazapineA-S Medication SolutionsANDACurrent
53002-1712MirtazapineMirtazapineRPK Pharmaceuticals, Inc.ANDACurrent
53002-1712MirtazapineMirtazapineRPK Pharmaceuticals, Inc.ANDACurrent
53808-0482MirtazapineMirtazapineState of Florida DOH Central PharmacyANDACurrent
53808-0483MirtazapineMirtazapineState of Florida DOH Central PharmacyANDACurrent
53808-0484MirtazapineMirtazapineState of Florida DOH Central PharmacyANDACurrent
55154-7297MirtazapineMirtazapineCardinal HealthANDACurrent
55154-7297MirtazapineMirtazapineCardinal HealthANDACurrent
55154-7297MirtazapineMirtazapineCardinal HealthANDACurrent
55154-7297MirtazapineMirtazapineCardinal HealthANDACurrent
55154-7297MirtazapineMirtazapineCardinal Health 107, LLCANDACurrent
55154-8145MirtazapineMirtazapineCardinal Health 107, LLCANDACurrent
55154-8145MirtazapineMirtazapineCardinal HealthANDACurrent
55700-249MirtazapineMirtazapineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-249MirtazapineMirtazapineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-249MirtazapineMirtazapineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-249MirtazapineMirtazapineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-341MirtazapineMirtazapineLake Erie Medical Medical DBA Quality Care Products LLCANDACurrent
55700-341MirtazapineMirtazapineLake Erie Medical Medical DBA Quality Care Products LLCANDACurrent
58118-0052MirtazapineMirtazapineClinical Solutions Wholesale, LLCANDACurrent
58118-0052MirtazapineMirtazapineClinical Solutions Wholesale, LLCANDACurrent
58118-0052MirtazapineMirtazapineClinical Solutions Wholesale, LLCANDACurrent
60505-0247MirtazapineMirtazapineApotex Corp.ANDACurrent
60505-0247MirtazapineMirtazapineApotex Corp.ANDACurrent
60505-0247MirtazapineMirtazapineApotex Corp.ANDACurrent
60505-0247MirtazapineMirtazapineApotex Corp.ANDACurrent
60505-0247MirtazapineMirtazapineApotex Corp.ANDACurrent
60505-0247MirtazapineMirtazapineApotex Corp.ANDACurrent
60505-0247MirtazapineMirtazapineApotex Corp.ANDACurrent
60505-0248MirtazapineMirtazapineApotex Corp.ANDACurrent
60505-0248MirtazapineMirtazapineApotex Corp.ANDACurrent
60505-0248MirtazapineMirtazapineApotex Corp.ANDACurrent
60505-0248MirtazapineMirtazapineApotex Corp.ANDACurrent
60505-0248MirtazapineMirtazapineApotex Corp.ANDACurrent
60505-0248MirtazapineMirtazapineApotex Corp.ANDACurrent
60505-0248MirtazapineMirtazapineApotex Corp.ANDACurrent
60505-0249MirtazapineMirtazapineApotex Corp.ANDACurrent
60505-0249MirtazapineMirtazapineApotex Corp.ANDACurrent
60505-0249MirtazapineMirtazapineApotex Corp.ANDACurrent
60505-0249MirtazapineMirtazapineApotex Corp.ANDACurrent
60505-0249MirtazapineMirtazapineApotex Corp.ANDACurrent
60505-0249MirtazapineMirtazapineApotex Corp.ANDACurrent
60505-0249MirtazapineMirtazapineApotex Corp.ANDACurrent
61786-208MirtazapineMirtazapineREMEDYREPACK INC.ANDACurrent
61919-153MIRTAZAPINEMIRTAZAPINEDirectRXANDACurrent
61919-153MirtazapineMirtazapineDirect_RxANDACurrent
61919-154MIRTAZAPINEMIRTAZAPINEDIRECT RXANDACurrent
61919-155MIRTAZAPINEMIRTAZAPINEDirect RxANDACurrent
63187-206MirtazapineMirtazapineProficient Rx LPANDACurrent
63187-206MirtazapineMirtazapineProficient Rx LPANDACurrent
63187-206MirtazapineMirtazapineProficient Rx LPANDACurrent
63187-471MirtazapineMirtazapineProficient Rx LPANDACurrent
63187-471MirtazapineMirtazapineProficient Rx LPANDACurrent
63187-471MirtazapineMirtazapineProficient Rx LPANDACurrent
63187-554MirtazapineMirtazapineProficient Rx LPANDACurrent
63187-554MirtazapineMirtazapineProficient Rx LPANDACurrent
63187-554MirtazapineMirtazapineProficient Rx LPANDACurrent
63739-098MirtazapineMirtazapineMcKesson Corporation dba SKY PackagingANDACurrent
63739-098MirtazapineMirtazapineMcKesson Corporation dba SKY PackagingANDACurrent
63739-098MirtazapineMirtazapineMcKesson Corporation dba SKY PackagingANDACurrent
63739-098MirtazapineMirtazapineMcKesson Corporation dba SKY PackagingANDACurrent
63739-099MirtazapineMirtazapineMcKesson Corporation dba SKY PackagingANDACurrent
63739-099MirtazapineMirtazapineMcKesson Corporation dba SKY PackagingANDACurrent
63739-099MirtazapineMirtazapineMcKesson Corporation dba SKY PackagingANDACurrent
63739-099MirtazapineMirtazapineMcKesson Corporation dba SKY PackagingANDACurrent
64725-0247MirtazapineMirtazapineTYA PharmaceuticalsANDACurrent
65084-475MirtazapineMirtazapineMcKesson Corporation dba RX PakANDACurrent
65084-475MirtazapineMirtazapineMcKesson Corporation dba RX PakANDACurrent
65084-476MirtazapineMirtazapineMcKesson Corporation dba RX PakANDACurrent
65084-476MirtazapineMirtazapineMcKesson Corporation dba RX PakANDACurrent
68071-4003MirtazapineMirtazapineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4045MirtazapineMirtazapineNuCare Pharmaceuticals,Inc.ANDACurrent