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McKinsey
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Medtronic
Fuji
McKesson
Cantor Fitzgerald
Covington
Dow
Mallinckrodt
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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021929

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NDA 021929 describes SYMBICORT, which is a drug marketed by Astrazeneca and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the SYMBICORT profile page.

The generic ingredient in SYMBICORT is budesonide; formoterol fumarate dihydrate. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the budesonide; formoterol fumarate dihydrate profile page.
Summary for 021929
Tradename:SYMBICORT
Applicant:Astrazeneca
Ingredient:budesonide; formoterol fumarate dihydrate
Patents:12
Formulation / Manufacturing:see details
Pharmacology for NDA: 021929
Suppliers and Packaging for NDA: 021929
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929 NDA AstraZeneca Pharmaceuticals LP 0186-0370 N 0186-0370-28
SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929 NDA AstraZeneca Pharmaceuticals LP 0186-0370 N 0186-0370-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.08MG/INH;0.0045MG/INH
Approval Date:Jul 21, 2006TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 11, 2020
Regulatory Exclusivity Use:INFORMATION ADDED TO LABELING TO SUPPORT THE USE OF SYMBICORT TO REDUCE EXACERBATIONS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Regulatory Exclusivity Expiration:Dec 20, 2020
Regulatory Exclusivity Use:INFORMATION ADDED TO THE CLINICAL TRIALS SECTION OF THE LABELING REGARDING A POSTMARKETING SAFETY AND EFFICACY STUDY EVALUATING THE RISK OF SERIOUS ASTHMA-RELATED EVENTS
Regulatory Exclusivity Expiration:Jan 27, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired US Patents for NDA 021929

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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