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Serving leading biopharmaceutical companies globally:

Moodys
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Argus Health
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Generated: October 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202121

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

The generic ingredient in PROGESTERONE is progesterone. There are fifty-two 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 NDA: 202121

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 202121

Ingredient-typeProgesterone

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)

Summary for product number 001

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

Summary for product number 002

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


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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
Queensland Health
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Fish and Richardson
Federal Trade Commission
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Chinese Patent Office

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