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Details for New Drug Application (NDA): 075906

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NDA 075906 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: 075906

Pharmacology for NDA: 075906


Suppliers and Packaging for NDA: 075906

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 075906 ANDA Fresenius Kabi USA, LLC 63323-261 63323-261-10 1 VIAL, MULTI-DOSE in 1 CARTON (63323-261-10) > 10 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Apr 25, 2001TE:AORLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.