Cheplapharm Arzneimittel Gmbh
FDA Approved Drugs

Cheplapharm Arzneimittel Gmbh

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

Discontinued RX Unclassified
  • Total Records 31
  • Latest Approval Date Aug 28, 2009
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
31
View
Unclassified
4
View
Discontinued
7
View
RX
20
View
Company Overview

Company

Cheplapharm Arzneimittel Gmbh

Country

Germany

Website

Visit Website

Email

Social Profiles

Company Snapshot

Cheplapharm Arzneimittel Gmbh

BAHNHOFSTR. 1A

Germany

www.cheplapharm.com/ View on Map
FDA Approved Drug Records ( 31 records )
1989
23 Jun
Discontinued Application: 19661

Drug Name

CYTOVENE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1989-06-23

19661 / 1

Active Ingredient

GANCICLOVIR SODIUM

Application Number

19661

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1989-06-23

Regulatory Status

Discontinued

1996
17 May
RX Application: 20457

Drug Name

ETOPOPHOS PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1996-05-17

20457 / 1

Active Ingredient

ETOPOSIDE PHOSPHATE

Application Number

20457

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1996-05-17

Regulatory Status

RX

1982
01 Jan
RX Application: 17533

Drug Name

KLONOPIN

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1982-01-01

17533 / 1

Active Ingredient

CLONAZEPAM

Application Number

17533

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17533

Drug Name

KLONOPIN

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

17533 / 2

Active Ingredient

CLONAZEPAM

Application Number

17533

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17533

Drug Name

KLONOPIN

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

17533 / 3

Active Ingredient

CLONAZEPAM

Application Number

17533

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

Regulatory Status

RX

1997
09 Apr
Discontinued Application: 17533

Drug Name

KLONOPIN

Product Number

5

Dosage Form

-

Strength

0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-04-09

17533 / 5

Active Ingredient

CLONAZEPAM

Application Number

17533

Product Number

5

Dosage Form

-

Strength

0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-04-09

Regulatory Status

Discontinued

1997
09 Apr
Discontinued Application: 17533

Drug Name

KLONOPIN

Product Number

6

Dosage Form

-

Strength

0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-04-09

17533 / 6

Active Ingredient

CLONAZEPAM

Application Number

17533

Product Number

6

Dosage Form

-

Strength

0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-04-09

Regulatory Status

Discontinued

2006
12 Jul
RX Application: 21949

Drug Name

PULMICORT FLEXHALER

Product Number

1

Dosage Form

-

Strength

0.08MG/INH

Approval Date

2006-07-12

21949 / 1

Active Ingredient

BUDESONIDE

Application Number

21949

Product Number

1

Dosage Form

-

Strength

0.08MG/INH

Approval Date

2006-07-12

Regulatory Status

RX

2006
12 Jul
RX Application: 21949

Drug Name

PULMICORT FLEXHALER

Product Number

2

Dosage Form

-

Strength

0.16MG/INH

Approval Date

2006-07-12

21949 / 2

Active Ingredient

BUDESONIDE

Application Number

21949

Product Number

2

Dosage Form

-

Strength

0.16MG/INH

Approval Date

2006-07-12

Regulatory Status

RX

1997
26 Sep
RX Application: 20639

Drug Name

SEROQUEL

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1997-09-26

20639 / 1

Active Ingredient

QUETIAPINE FUMARATE

Application Number

20639

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1997-09-26

Regulatory Status

RX

1997
26 Sep
RX Application: 20639

Drug Name

SEROQUEL

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1997-09-26

20639 / 2

Active Ingredient

QUETIAPINE FUMARATE

Application Number

20639

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1997-09-26

Regulatory Status

RX

1997
26 Sep
RX Application: 20639

Drug Name

SEROQUEL

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

1997-09-26

20639 / 3

Active Ingredient

QUETIAPINE FUMARATE

Application Number

20639

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

1997-09-26

Regulatory Status

RX

1998
20 Dec
Discontinued Application: 20639

Drug Name

SEROQUEL

Product Number

4

Dosage Form

-

Strength

EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-12-20

20639 / 4

Active Ingredient

QUETIAPINE FUMARATE

Application Number

20639

Product Number

4

Dosage Form

-

Strength

EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-12-20

Regulatory Status

Discontinued

2000
26 Jul
RX Application: 20639

Drug Name

SEROQUEL

Product Number

5

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2000-07-26

20639 / 5

Active Ingredient

QUETIAPINE FUMARATE

Application Number

20639

Product Number

5

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2000-07-26

Regulatory Status

RX

2005
04 Oct
RX Application: 20639

Drug Name

SEROQUEL

Product Number

6

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2005-10-04

20639 / 6

Active Ingredient

QUETIAPINE FUMARATE

Application Number

20639

Product Number

6

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2005-10-04

Regulatory Status

RX

2005
04 Oct
RX Application: 20639

Drug Name

SEROQUEL

Product Number

7

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2005-10-04

20639 / 7

Active Ingredient

QUETIAPINE FUMARATE

Application Number

20639

Product Number

7

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2005-10-04

Regulatory Status

RX

2007
17 May
RX Application: 22047

Drug Name

SEROQUEL XR

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2007-05-17

22047 / 1

Active Ingredient

QUETIAPINE FUMARATE

Application Number

22047

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2007-05-17

Regulatory Status

RX

2007
17 May
RX Application: 22047

Drug Name

SEROQUEL XR

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2007-05-17

22047 / 2

Active Ingredient

QUETIAPINE FUMARATE

Application Number

22047

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2007-05-17

Regulatory Status

RX

2007
17 May
RX Application: 22047

Drug Name

SEROQUEL XR

Product Number

3

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2007-05-17

22047 / 3

Active Ingredient

QUETIAPINE FUMARATE

Application Number

22047

Product Number

3

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2007-05-17

Regulatory Status

RX

2007
17 May
RX Application: 22047

Drug Name

SEROQUEL XR

Product Number

4

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2007-05-17

22047 / 4

Active Ingredient

QUETIAPINE FUMARATE

Application Number

22047

Product Number

4

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2007-05-17

Regulatory Status

RX

2008
11 Aug
RX Application: 22047

Drug Name

SEROQUEL XR

Product Number

5

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2008-08-11

22047 / 5

Active Ingredient

QUETIAPINE FUMARATE

Application Number

22047

Product Number

5

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2008-08-11

Regulatory Status

RX

-
Unclassified Application: 22172

Drug Name

SEROQUEL XR

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

22172 / 1

Active Ingredient

QUETIAPINE FUMARATE

Application Number

22172

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 22172

Drug Name

SEROQUEL XR

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

-

22172 / 2

Active Ingredient

QUETIAPINE FUMARATE

Application Number

22172

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 22172

Drug Name

SEROQUEL XR

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

-

22172 / 3

Active Ingredient

QUETIAPINE FUMARATE

Application Number

22172

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 22172

Drug Name

SEROQUEL XR

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

-

22172 / 4

Active Ingredient

QUETIAPINE FUMARATE

Application Number

22172

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

-

Regulatory Status

Unclassified

2001
29 Mar
RX Application: 21304

Drug Name

VALCYTE

Product Number

1

Dosage Form

-

Strength

EQ 450MG BASE

Approval Date

2001-03-29

21304 / 1

Active Ingredient

VALGANCICLOVIR HYDROCHLORIDE

Application Number

21304

Product Number

1

Dosage Form

-

Strength

EQ 450MG BASE

Approval Date

2001-03-29

Regulatory Status

RX

2009
28 Aug
RX Application: 22257

Drug Name

VALCYTE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2009-08-28

22257 / 1

Active Ingredient

VALGANCICLOVIR HYDROCHLORIDE

Application Number

22257

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2009-08-28

Regulatory Status

RX

1995
22 Nov
Discontinued Application: 20438

Drug Name

VESANOID

Product Number

1

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-11-22

20438 / 1

Active Ingredient

TRETINOIN

Application Number

20438

Product Number

1

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-11-22

Regulatory Status

Discontinued

1998
30 Apr
Discontinued Application: 20896

Drug Name

XELODA

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1998-04-30

20896 / 1

Active Ingredient

CAPECITABINE

Application Number

20896

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1998-04-30

Regulatory Status

Discontinued

1998
30 Apr
Discontinued Application: 20896

Drug Name

XELODA

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1998-04-30

20896 / 2

Active Ingredient

CAPECITABINE

Application Number

20896

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1998-04-30

Regulatory Status

Discontinued

1999
23 Apr
RX Application: 20766

Drug Name

XENICAL

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

1999-04-23

20766 / 1

Active Ingredient

ORLISTAT

Application Number

20766

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

1999-04-23

Regulatory Status

RX

Related Databases
  • FDA Inspections
    0 View
  • EDQM CEP
    0 View
  • KDMF
    0 View
  • Japan DMF
    0 View
  • Eudra GMP
    0 View
  • NDC Database
    0 View
  • FDA Approved Drugs Database
    31 View
  • Drug Prices in Switzerland
    0 View
Drug Status Breakdown
31 total
  • Discontinued
  • RX
  • Unclassified
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

CYTOVENE

Application Number

19661

Product Number

1

Active Ingredient

GANCICLOVIR SODIUM

Dosage Form

-

Strength

EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

Create a New Buying Request

Fields marked with * are mandatory.

Please enter quantity.
Please select a unit.
Please select quality standard.
Please select request type.
Please provide product specifications.
Please enter additional details.
Please select shipping preference.
Notice: By submitting this buying request, the provided product details and requirements may be published publicly on our marketplace.
Login to Submit