Details for New Drug Application (NDA): 020929

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NDA 020929 describes PULMICORT RESPULES, which is a drug marketed by Astrazeneca and is included in one NDA. It is available from one supplier. Additional details are available on the PULMICORT RESPULES profile page.

The generic ingredient in PULMICORT RESPULES is budesonide. There are twenty-two drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Summary for 020929

Tradename:	PULMICORT RESPULES
Applicant:	Astrazeneca
Ingredient:	budesonide
Patents:	0

Pharmacology for NDA: 020929

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 020929

Anti-Inflammatory Agents
Bronchodilator Agents
Glucocorticoids

Suppliers and Packaging for NDA: 020929

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929	NDA	AstraZeneca Pharmaceuticals LP	0186-1988	0186-1988-04	6 POUCH in 1 CARTON (0186-1988-04) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE
PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929	NDA	AstraZeneca Pharmaceuticals LP	0186-1989	0186-1989-04	6 POUCH in 1 CARTON (0186-1989-04) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;INHALATION			Strength	0.25MG/2ML
Approval Date:	Aug 8, 2000	TE:	AN	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;INHALATION			Strength	0.5MG/2ML
Approval Date:	Aug 8, 2000	TE:	AN	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;INHALATION			Strength	1MG/2ML
Approval Date:	Aug 8, 2000	TE:	AN	RLD:	Yes

Expired US Patents for NDA 020929

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-003	Aug 8, 2000	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-001	Aug 8, 2000	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-001	Aug 8, 2000	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-002	Aug 8, 2000	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-002	Aug 8, 2000	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-002	Aug 8, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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