FDA.reportPublic FDA data

Application 205229

Type
ANDA
Sponsor
XIROMED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROGESTERONEPROGESTERONECAPSULE;ORAL100MGNoNo
002PROGESTERONEPROGESTERONECAPSULE;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-157ProgesteroneProgesteroneNorthstar Rx LLCANDACurrent
16714-158ProgesteroneProgesteroneNorthstar Rx LLCANDACurrent
68071-2768ProgesteroneProgesteroneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2770ProgesteroneProgesteroneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2832ProgesteroneProgesteroneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2840ProgesteroneProgesteroneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2840ProgesteroneProgesteroneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8295ProgesteroneProgesteronePreferred Pharmaceuticals Inc.ANDACurrent
68788-8296ProgesteroneProgesteronePreferred Pharmaceuticals Inc.ANDACurrent
70518-3286ProgesteroneProgesteroneREMEDYREPACK INC.ANDACurrent
70700-162ProgesteroneProgesteroneXiromed, LLCANDACurrent
70700-162ProgesteroneProgesteroneXiromed, LLCANDACurrent
70700-163ProgesteroneProgesteroneXiromed, LLCANDACurrent
70700-163ProgesteroneProgesteroneXiromed, LLCANDACurrent
70934-914ProgesteroneProgesteroneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-669ProgesteroneProgesteroneProficient Rx LPANDACurrent
71205-684ProgesteroneProgesteroneProficient Rx LPANDACurrent
71205-902ProgesteroneProgesteroneProficient Rx LPANDACurrent
71205-902ProgesteroneProgesteroneProficient Rx LPANDACurrent
71205-903ProgesteroneProgesteroneProficient Rx LPANDACurrent
71205-903ProgesteroneProgesteroneProficient Rx LPANDACurrent
71335-1913ProgesteroneProgesteroneBryant Ranch PrepackANDACurrent
71335-1990ProgesteroneProgesteroneBryant Ranch PrepackANDACurrent
71335-1990ProgesteroneProgesteroneBryant Ranch PrepackANDACurrent
72189-347PROGESTERONEPROGESTERONEDirect RxANDACurrent
72189-347PROGESTERONEPROGESTERONEDirect RxANDACurrent
76420-267ProgesteroneProgesteroneAsclemed USA, Inc.ANDACurrent
76420-281ProgesteroneProgesteroneAsclemed USA, Inc.ANDACurrent
76420-282ProgesteroneProgesteroneAsclemed USA, Inc.ANDACurrent