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Serving 500+ biopharmaceutical companies globally:

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Generated: July 25, 2017

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 drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.

Summary for NDA: 081271

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

Pharmacology for NDA: 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
TEXACORT
hydrocortisone
SOLUTION;TOPICAL 081271 ANDA Mission Pharmacal Company 0178-0455 0178-0455-03 3 mL in 1 PACKET (0178-0455-03)

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

Baxter
Cipla
Harvard Business School
UBS
Argus Health
Deloitte
Boehringer Ingelheim
Express Scripts
Teva
Julphar

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