FDA.reportPublic FDA data

Application 211908

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZIPRASIDONE MESYLATEZIPRASIDONE MESYLATEINJECTABLE;INTRAMUSCULAREQ 20MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-061ziprasidone mesylateziprasidone mesylateDr.Reddy's Laboratories, Inc.ANDACurrent
43598-061ziprasidone mesylateziprasidone mesylateDr.Reddy's Laboratories, Inc.ANDACurrent
43598-848ziprasidone mesylateziprasidone mesylateDr.Reddy's Laboratories, Inc.ANDACurrent
43598-848ziprasidone mesylateziprasidone mesylateDr.Reddy's Laboratories, Inc.ANDACurrent
43598-848ziprasidone mesylateziprasidone mesylateDr.Reddy's Laboratories, Inc.ANDACurrent
43598-848ziprasidone mesylateziprasidone mesylateDr. ReddyANDACurrent
43598-848ziprasidone mesylateziprasidone mesylateDr. ReddyANDACurrent
51662-1564ZIPRASIDONE MESYLATEZIPRASIDONE MESYLATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
68083-340ziprasidone mesylateziprasidone mesylateGland Pharma LimitedANDACurrent
68083-340ziprasidone mesylateziprasidone mesylateGland Pharma LimitedANDACurrent
68083-340ziprasidone mesylateziprasidone mesylateGland Pharma LimitedANDACurrent
68083-340ziprasidone mesylateziprasidone mesylateGland Pharma LimitedANDACurrent
72266-160ziprasidone mesylateziprasidone mesylateFosun Pharma USA Inc.ANDACurrent
72266-160Ziprasidone MesylateZiprasidone MesylateFosun Pharma USA Inc.ANDACurrent
72266-160Ziprasidone MesylateZiprasidone MesylateFosun Pharma USA Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62180ORIG2020-03-17