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Generated: January 18, 2019

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Details for New Drug Application (NDA): 207029

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Summary for 207029
Tradename:HYDROCORTISONE
Applicant:Pii
Ingredient:hydrocortisone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207029
Medical Subject Heading (MeSH) Categories for 207029
Suppliers and Packaging for NDA: 207029
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE hydrocortisone TABLET;ORAL 207029 ANDA Vensun Pharmaceuticals, Inc. 42543-140 42543-140-50 50 TABLET in 1 BOTTLE, PLASTIC (42543-140-50)
HYDROCORTISONE hydrocortisone TABLET;ORAL 207029 ANDA Vensun Pharmaceuticals, Inc. 42543-141 42543-141-01 100 TABLET in 1 BOTTLE, PLASTIC (42543-141-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 27, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 27, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Apr 27, 2017TE:ABRLD:No

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