FDA.report

Application 077206

Type
ANDA
Sponsor
AUROBINDO PHARMA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDETABLET;ORALEQ 25MG BASENoNo
002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDETABLET;ORALEQ 50MG BASENoNo
003SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDETABLET;ORALEQ 100MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
13107-011Sertraline HydrochlorideSertraline HydrochlorideAurolife Pharma LLCANDACurrent
13107-012Sertraline HydrochlorideSertraline HydrochlorideAurolife Pharma LLCANDACurrent
13107-013Sertraline HydrochlorideSertraline HydrochlorideAurolife Pharma LLCANDACurrent
16714-611Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-611Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-611Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-611Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-611Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-611Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-611Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-612Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-612Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-612Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-612Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-612Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-612Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-612Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-613Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-613Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-613Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-613Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-613Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-613Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-613Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
42708-050Sertraline HydrochlorideSertraline HydrochlorideQPharma IncANDACurrent
42708-124Sertraline HydrochlorideSertraline HydrochlorideQPharma IncANDACurrent
42708-124Sertraline HydrochlorideSertraline HydrochlorideQPharma IncANDACurrent
42708-124Sertraline HydrochlorideSertraline HydrochlorideQPharma IncANDACurrent
43353-447Sertraline HydrochlorideSertraline HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-1847Sertraline HydrochlorideSertraline HydrochlorideA-S Medication SolutionsANDACurrent
50090-1847Sertraline HydrochlorideSertraline HydrochlorideA-S Medication SolutionsANDACurrent
50090-2080Sertraline HydrochlorideSertraline HydrochlorideA-S Medication SolutionsANDACurrent
50090-2080Sertraline HydrochlorideSertraline HydrochlorideA-S Medication SolutionsANDACurrent
50090-3112Sertraline HydrochlorideSertraline HydrochlorideA-S Medication SolutionsANDACurrent
50436-0011Sertraline HydrochlorideSertraline HydrochlorideUnit Dose ServicesANDACurrent
50436-0012Sertraline HydrochlorideSertraline HydrochlorideUnit Dose ServicesANDACurrent
50436-0013Sertraline HydrochlorideSertraline HydrochlorideUnit Dose ServicesANDACurrent
50436-0611Sertraline HydrochlorideSertraline HydrochlorideUnit Dose ServicesANDACurrent
51655-173Sertraline HydrochlorideSertraline HydrochlorideNorthwind PharmaceuticalsANDACurrent
51655-173Sertraline HydrochlorideSertraline HydrochlorideNorthwind PharmaceuticalsANDACurrent
51655-265Sertraline HydrochlorideSertraline HydrochlorideNorthwind PharmaceuticalsANDACurrent
51655-265Sertraline HydrochlorideSertraline HydrochlorideNorthwind PharmaceuticalsANDACurrent
53002-2507Sertraline HydrochlorideSertraline HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-3192Sertraline HydrochlorideSertraline HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-3192Sertraline HydrochlorideSertraline HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-3215Sertraline HydrochlorideSertraline HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53808-1127Sertraline HydrochlorideSertraline HydrochlorideDOH CENTRAL PHARMACYANDACurrent
55700-340Sertraline HydrochlorideSertraline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-340Sertraline HydrochlorideSertraline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-340Sertraline HydrochlorideSertraline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-340Sertraline HydrochlorideSertraline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-340Sertraline HydrochlorideSertraline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-362Sertraline HydrochlorideSertraline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-362Sertraline HydrochlorideSertraline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-362Sertraline HydrochlorideSertraline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-362Sertraline HydrochlorideSertraline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-362Sertraline HydrochlorideSertraline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-562Sertraline HydrochlorideSertraline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-562Sertraline HydrochlorideSertraline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-562Sertraline HydrochlorideSertraline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-091Sertraline HydrochlorideSertraline HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-091Sertraline HydrochlorideSertraline HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-611Sertraline HydrochlorideSertraline HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-612Sertraline HydrochlorideSertraline HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
61919-014SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-014SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEDIRECT RXANDACurrent
63629-6370Sertraline HydrochlorideSertraline HydrochlorideBryant Ranch PrepackANDACurrent
63629-6370Sertraline HydrochlorideSertraline HydrochlorideBryant Ranch PrepackANDACurrent
63629-8125Sertraline HydrochlorideSertraline HydrochlorideBryant Ranch PrepackANDACurrent
63629-8125Sertraline HydrochlorideSertraline HydrochlorideBryant Ranch PrepackANDACurrent
63629-8127Sertraline HydrochlorideSertraline HydrochlorideBryant Ranch PrepackANDACurrent
63629-8127Sertraline HydrochlorideSertraline HydrochlorideBryant Ranch PrepackANDACurrent
63629-8128Sertraline HydrochlorideSertraline HydrochlorideBryant Ranch PrepackANDACurrent
63629-8128Sertraline HydrochlorideSertraline HydrochlorideBryant Ranch PrepackANDACurrent
63739-490Sertraline HydrochlorideSertraline HydrochlorideMcKesson Packaging Services Business Unit of McKesson CorporationANDACurrent
65862-011Sertraline HydrochlorideSertraline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-011Sertraline HydrochlorideSertraline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-011Sertraline HydrochlorideSertraline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-011Sertraline HydrochlorideSertraline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-011Sertraline HydrochlorideSertraline HydrochlorideAurobindo Pharma LimitedANDACurrent

Documents

DocumentSubmission typeDate
31206ORIG2005-09-22