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Johnson and Johnson
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Federal Trade Commission
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Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202145

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NDA 202145 describes HYDROCORTISONE BUTYRATE, which is a drug marketed by Actavis Mid Atlantic, Glenmark Generics, Taro Pharm Inds, Teligent Pharma Inc, and Taro, and is included in six NDAs. It is available from four suppliers. Additional details are available on the HYDROCORTISONE BUTYRATE profile page.

The generic ingredient in HYDROCORTISONE BUTYRATE is hydrocortisone butyrate. There are sixty-four drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the hydrocortisone butyrate profile page.
Summary for 202145
Tradename:HYDROCORTISONE BUTYRATE
Applicant:Glenmark Generics
Ingredient:hydrocortisone butyrate
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 202145
Suppliers and Packaging for NDA: 202145
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM;TOPICAL 202145 ANDA Glenmark Pharmaceuticals Inc., USA 68462-464 N 68462-464-17
HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM;TOPICAL 202145 ANDA Glenmark Pharmaceuticals Inc., USA 68462-464 N 68462-464-47

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Sep 27, 2013TE:AB2RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Chubb
Merck
AstraZeneca
Dow
McKesson
Queensland Health
Johnson and Johnson
Farmers Insurance

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