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Generated: June 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040425

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NDA 040425 describes FLUDROCORTISONE ACETATE, which is a drug marketed by Hikma Pharms, Barr, and Impax Labs, and is included in three NDAs. It is available from ten suppliers. Additional details are available on the FLUDROCORTISONE ACETATE profile page.

The generic ingredient in FLUDROCORTISONE ACETATE is fludrocortisone acetate. There are four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the fludrocortisone acetate profile page.

Summary for NDA: 040425

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

Suppliers and Packaging for NDA: 040425

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUDROCORTISONE ACETATE
fludrocortisone acetate
TABLET;ORAL 040425 ANDA Teva Pharmaceuticals USA, Inc. 0555-0997 0555-0997-02 100 TABLET in 1 BOTTLE (0555-0997-02)
FLUDROCORTISONE ACETATE
fludrocortisone acetate
TABLET;ORAL 040425 ANDA PD-Rx Pharmaceuticals, Inc. 43063-714 43063-714-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-714-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.1MG
Approval Date:Jan 21, 2003TE:ABRLD:No


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Dow
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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.

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