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Generated: September 23, 2018

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Details for New Drug Application (NDA): 202121

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NDA 202121 describes PROGESTERONE, which is a drug marketed by Amneal Pharms Ny, Bionpharma Inc, Dr Reddys Labs Inc, Sandoz Inc, Sofgen Pharms, Teva Pharms, Actavis Labs Ut Inc, Fresenius Kabi Usa, Hikma Farmaceutica, Lilly, and Luitpold, and is included in eleven NDAs. It is available from seventeen suppliers. Additional details are available on the PROGESTERONE profile page.

The generic ingredient in PROGESTERONE is progesterone. There are fifty-six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the progesterone profile page.
Summary for 202121
Tradename:PROGESTERONE
Applicant:Teva Pharms
Ingredient:progesterone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202121
Ingredient-typeProgesterone
Medical Subject Heading (MeSH) Categories for 202121
Suppliers and Packaging for NDA: 202121
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROGESTERONE progesterone CAPSULE;ORAL 202121 ANDA Teva Pharmaceuticals USA, Inc. 0093-5353 0093-5353-01 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0093-5353-01)
PROGESTERONE progesterone CAPSULE;ORAL 202121 ANDA Teva Pharmaceuticals USA, Inc. 0093-5354 0093-5354-01 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0093-5354-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Feb 29, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Feb 29, 2012TE:ABRLD:No

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