Drug Approvals

New! As of May 1, 2004, New and Generic Drug Approvals 1998-2004, will not be updated.
Please use Drugs@FDA for all drug approval information, which includes the content of this page.

Product Name	Company	Application #	Approval Date	Letter Posted	Label Posted	Review Posted
Quinapril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Tentatively Approved	Ranbaxy Laboratories	75-607	3/12/04
Quinapril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx	Teva Pharmaceuticals	75-504	5/30/03
Quinapril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Tentatively Approved	Amide Pharmaceuticals	76-459	3/9/04
Quinapril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Tentatively Approved	Andrx Pharmaceuticals	76-049	6/11/03
Quinaretic (Quinapril Hydrochloride & Hydrochlorothiazide) Tablets, 10 & 20mg, Rx	Amide Pharmaceutical	76-374	3/31/04	4/7/04
Quinapril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx, Tentatively Approved	Teva Pharmaceuticals	75-504	2/8/02	4/10/03
Quinidex Extentabs (quinidine sulfate extended-release tablets), 300 mg	Wyeth-Ayerst Laboratories	NDA 12-796/S-049	2/21/02	4/9/03	5/14/2003
Quixin (levofloxacin ophthalmic solution), 0.5%, Rx	Santen Incorporated	NDA 21-199/S3	6/4/02	6/17/02	6/7/02
Quixin (levofloxacin ophthalmic solution), 0.5%, Rx	Santen Incorporated	NDA 21-199/S2	4/18/02	4/22/02	4/18/02
Quixin (levofloxacin ophthalmic solution) Sterile, 0.5%, Rx	Santen Incorporated	NDA 21-199	8/18/00	8/28/00	8/28/00	3/24/04
	Quixin Indications: treatment of bacterial conjunctivitis.
Qvar (beclomethasone dipropionate HFA) Inhalation Aerosol, Rx	3M Pharmaceuticals	NDA 20-911/S8	8/1/03	8/15/03
Qvar Inhalation Aerosol (beclomethasone dipropionate HFA), Rx	3M Pharmaceuticals	NDA 20-911/S5	5/9/02	5/21/02
Qvar Inhalation Aerosol (beclomethasone dipropionate HFA 40 mcg and 80 mcg), Rx	3M Pharmaceuticals	NDA 20-911	9/15/00			2/9/04
	QVar Indication: for the maintenance treatment of asthma as prophylactic therapy. QVar is also indicated for asthma patients who require systemic corticosteroid administration, where adding QVar may reduce or eliminate the need for the systemic corticosteroids.

Product Name

Company

Application #

Approval
Date

Letter
Posted

Label
Posted

Review
Posted

Quinapril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Tentatively Approved

Ranbaxy Laboratories

75-607

3/12/04

Quinapril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx

Teva Pharmaceuticals

75-504

5/30/03

Quinapril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Tentatively Approved

Amide Pharmaceuticals

76-459

3/9/04

Quinapril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Tentatively Approved

Andrx Pharmaceuticals

76-049

6/11/03

Quinaretic (Quinapril Hydrochloride & Hydrochlorothiazide) Tablets, 10 & 20mg, Rx

Amide Pharmaceutical

76-374

3/31/04

4/7/04

Quinapril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx, Tentatively Approved

Teva Pharmaceuticals

75-504

2/8/02

4/10/03

Quinidex Extentabs (quinidine sulfate extended-release tablets),
300 mg

Wyeth-Ayerst Laboratories

NDA 12-796/S-049

2/21/02

4/9/03

5/14/2003

Quixin (levofloxacin ophthalmic solution), 0.5%, Rx

Santen Incorporated

NDA 21-199/S3

6/4/02

6/17/02

6/7/02

Quixin (levofloxacin ophthalmic solution), 0.5%, Rx

Santen Incorporated

NDA 21-199/S2

4/18/02

4/22/02

4/18/02

Quixin (levofloxacin ophthalmic solution) Sterile, 0.5%, Rx

Santen Incorporated

NDA 21-199

8/18/00

8/28/00

3/24/04

Quixin Indications: treatment of bacterial conjunctivitis.

Qvar (beclomethasone dipropionate HFA) Inhalation Aerosol, Rx

3M Pharmaceuticals

NDA 20-911/S8

8/1/03

8/15/03

Qvar Inhalation Aerosol (beclomethasone dipropionate HFA), Rx

3M Pharmaceuticals

NDA 20-911/S5

5/9/02

5/21/02

Qvar Inhalation Aerosol (beclomethasone dipropionate HFA 40 mcg and 80 mcg), Rx

3M Pharmaceuticals

NDA 20-911

9/15/00

2/9/04

QVar Indication: for the maintenance treatment of asthma as prophylactic therapy. QVar is also indicated for asthma patients who require systemic corticosteroid administration, where adding QVar may reduce or eliminate the need for the systemic corticosteroids.

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