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Details for New Drug Application (NDA): 200456

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NDA 200456 describes PROGESTERONE, which is a drug marketed by Bionpharma Inc, Fresenius Kabi Usa, Teva Pharms, Hikma Farmaceutica, Lilly, Luitpold, Sofgen Pharms, and Allergan Sales Llc, and is included in eight NDAs. It is available from thirteen suppliers. Additional details are available on the PROGESTERONE profile page.

The generic ingredient in PROGESTERONE is progesterone. There are forty-nine drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the progesterone profile page.

Summary for NDA: 200456

Pharmacology for NDA: 200456


Suppliers and Packaging for NDA: 200456

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 200456 ANDA Akorn, Inc. 17478-766 17478-766-10 100 CAPSULE in 1 BOTTLE, PLASTIC (17478-766-10)
CAPSULE;ORAL 200456 ANDA Akorn, Inc. 17478-767 17478-767-10 100 CAPSULE in 1 BOTTLE, PLASTIC (17478-767-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Sep 28, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Sep 28, 2012TE:ABRLD:No

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