FDA.reportPublic FDA data

Application 200456

Type
ANDA
Sponsor
SOFGEN PHARMS

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
17478-766ProgesteroneProgesteroneAkorn, Inc.ANDACurrent
17478-766ProgesteroneProgesteroneAkornANDACurrent
17478-766ProgesteroneProgesteroneAkorn, Inc.ANDACurrent
17478-767ProgesteroneProgesteroneAkorn, Inc.ANDACurrent
17478-767ProgesteroneProgesteroneAkorn, Inc.ANDACurrent
17478-767ProgesteroneProgesteroneAkornANDACurrent
50090-2527ProgesteroneProgesteroneA-S Medication SolutionsANDACurrent
50090-2527ProgesteroneProgesteroneA-S Medication SolutionsANDACurrent
53002-1760ProgesteroneProgesteroneRPK Pharmaceuticals, Inc.ANDACurrent
68788-7199ProgesteroneProgesteronePreferred Pharmaceuticals Inc.ANDACurrent
68788-7199ProgesteroneProgesteronePreferred Pharmaceuticals Inc.ANDACurrent
68788-7199ProgesteroneProgesteronePreferred Pharmaceuticals Inc.ANDACurrent
71205-293ProgesteroneProgesteroneProficient Rx LPANDACurrent
71205-293ProgesteroneProgesteroneProficient Rx LPANDACurrent
71205-293ProgesteroneProgesteroneProficient Rx LPANDACurrent
71335-0825ProgesteroneProgesteroneBryant Ranch PrepackANDACurrent
71335-0825ProgesteroneProgesteroneBryant Ranch PrepackANDACurrent
71335-0825ProgesteroneProgesteroneBryant Ranch PrepackANDACurrent
71335-0825ProgesteroneProgesteroneBryant Ranch PrepackANDACurrent
71335-0835ProgesteroneProgesteroneBryant Ranch PrepackANDACurrent
71335-0835ProgesteroneProgesteroneBryant Ranch PrepackANDACurrent
71335-0835ProgesteroneProgesteroneBryant Ranch PrepackANDACurrent
76420-070ProgesteroneProgesteroneAsclemed USA, Inc.ANDACurrent
76420-071ProgesteroneProgesteroneAsclemed USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9826ORIG2012-10-02