Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 081271

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NDA 081271 describes TEXACORT, which is a drug marketed by Mission Pharma and is included in two NDAs. It is available from one supplier. Additional details are available on the TEXACORT profile page.

The generic ingredient in TEXACORT is hydrocortisone. There are sixty-seven drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
Summary for 081271
Tradename:TEXACORT
Applicant:Mission Pharma
Ingredient:hydrocortisone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 081271
Medical Subject Heading (MeSH) Categories for 081271
Suppliers and Packaging for NDA: 081271
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEXACORT hydrocortisone SOLUTION;TOPICAL 081271 ANDA Mission Pharmacal Company 0178-0455 0178-0455-01 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0178-0455-01) > 30 mL in 1 BOTTLE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength2.5%
Approval Date:Apr 17, 1992TE:RLD:No

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