EMD Serono
FDA Approved Drugs

EMD Serono

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 Unclassified
  • Total Records 32
  • Latest Approval Date Dec 28, 1990
  • Data Source FDA
  • First Approval Date Mar 22, 1982
All
32
View
Unclassified
27
View
Discontinued
5
View
Company Overview

Company

EMD Serono

Country

U.S.A

Website

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Company Snapshot

EMD Serono

One Technology Place, Rockland, MA 02370

U.S.A

www.emdserono.com/us-en?global_redirect=1 View on Map
FDA Approved Drug Records ( 32 records )
1990
28 Dec
Discontinued Application: 19863

Drug Name

GEREF

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/AMP **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-28

19863 / 1

Active Ingredient

SERMORELIN ACETATE

Application Number

19863

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/AMP **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-28

Regulatory Status

Discontinued

-
Unclassified Application: 20378

Drug Name

GONAL-F

Product Number

1

Dosage Form

-

Strength

75 IU/VIAL

Approval Date

-

20378 / 1

Active Ingredient

FOLLITROPIN ALFA/BETA

Application Number

20378

Product Number

1

Dosage Form

-

Strength

75 IU/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 20378

Drug Name

GONAL-F

Product Number

2

Dosage Form

-

Strength

150 IU/VIAL

Approval Date

-

20378 / 2

Active Ingredient

FOLLITROPIN ALFA/BETA

Application Number

20378

Product Number

2

Dosage Form

-

Strength

150 IU/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 20378

Drug Name

GONAL-F

Product Number

3

Dosage Form

-

Strength

37.5 IU/VIAL

Approval Date

-

20378 / 3

Active Ingredient

FOLLITROPIN ALFA/BETA

Application Number

20378

Product Number

3

Dosage Form

-

Strength

37.5 IU/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 20378

Drug Name

GONAL-F

Product Number

4

Dosage Form

-

Strength

1,050 IU/VIAL

Approval Date

-

20378 / 4

Active Ingredient

FOLLITROPIN ALFA/BETA

Application Number

20378

Product Number

4

Dosage Form

-

Strength

1,050 IU/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 20378

Drug Name

GONAL-F

Product Number

5

Dosage Form

-

Strength

450 IU/VIAL

Approval Date

-

20378 / 5

Active Ingredient

FOLLITROPIN ALFA/BETA

Application Number

20378

Product Number

5

Dosage Form

-

Strength

450 IU/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 21765

Drug Name

GONAL-F

Product Number

1

Dosage Form

-

Strength

37.5 IU/VIAL

Approval Date

-

21765 / 1

Active Ingredient

FOLLITROPIN ALFA/BETA

Application Number

21765

Product Number

1

Dosage Form

-

Strength

37.5 IU/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 21765

Drug Name

GONAL-F

Product Number

3

Dosage Form

-

Strength

150 IU/VIAL

Approval Date

-

21765 / 3

Active Ingredient

FOLLITROPIN ALFA/BETA

Application Number

21765

Product Number

3

Dosage Form

-

Strength

150 IU/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 21765

Drug Name

GONAL-F RFF

Product Number

2

Dosage Form

-

Strength

75 IU/VIAL

Approval Date

-

21765 / 2

Active Ingredient

FOLLITROPIN ALFA/BETA

Application Number

21765

Product Number

2

Dosage Form

-

Strength

75 IU/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 21684

Drug Name

GONAL-F RFF REDI-JECT

Product Number

1

Dosage Form

-

Strength

300 IU/0.5ML

Approval Date

-

21684 / 1

Active Ingredient

FOLLITROPIN ALFA/BETA

Application Number

21684

Product Number

1

Dosage Form

-

Strength

300 IU/0.5ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 21684

Drug Name

GONAL-F RFF REDI-JECT

Product Number

2

Dosage Form

-

Strength

450 IU/0.75ML

Approval Date

-

21684 / 2

Active Ingredient

FOLLITROPIN ALFA/BETA

Application Number

21684

Product Number

2

Dosage Form

-

Strength

450 IU/0.75ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 21684

Drug Name

GONAL-F RFF REDI-JECT

Product Number

3

Dosage Form

-

Strength

900 IU/1.5ML

Approval Date

-

21684 / 3

Active Ingredient

FOLLITROPIN ALFA/BETA

Application Number

21684

Product Number

3

Dosage Form

-

Strength

900 IU/1.5ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 21684

Drug Name

GONAL-F RFF REDI-JECT

Product Number

4

Dosage Form

-

Strength

150 IU/0.25ML

Approval Date

-

21684 / 4

Active Ingredient

FOLLITROPIN ALFA/BETA

Application Number

21684

Product Number

4

Dosage Form

-

Strength

150 IU/0.25ML

Approval Date

-

Regulatory Status

Unclassified

1987
23 Dec
Discontinued Application: 19297

Drug Name

NOVANTRONE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/10ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-12-23

19297 / 1

Active Ingredient

MITOXANTRONE HYDROCHLORIDE

Application Number

19297

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/10ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-12-23

Regulatory Status

Discontinued

1987
23 Dec
Discontinued Application: 19297

Drug Name

NOVANTRONE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-12-23

19297 / 2

Active Ingredient

MITOXANTRONE HYDROCHLORIDE

Application Number

19297

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-12-23

Regulatory Status

Discontinued

1987
23 Dec
Discontinued Application: 19297

Drug Name

NOVANTRONE

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE/15ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-12-23

19297 / 3

Active Ingredient

MITOXANTRONE HYDROCHLORIDE

Application Number

19297

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE/15ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-12-23

Regulatory Status

Discontinued

-
Unclassified Application: 21149

Drug Name

OVIDREL

Product Number

1

Dosage Form

-

Strength

0.25MG/VIAL

Approval Date

-

21149 / 1

Active Ingredient

CHORIOGONADOTROPIN ALFA

Application Number

21149

Product Number

1

Dosage Form

-

Strength

0.25MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 21149

Drug Name

OVIDREL

Product Number

2

Dosage Form

-

Strength

EQ 0.25MG /0.5ML

Approval Date

-

21149 / 2

Active Ingredient

CHORIOGONADOTROPIN ALFA

Application Number

21149

Product Number

2

Dosage Form

-

Strength

EQ 0.25MG /0.5ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 19764

Drug Name

SAIZEN

Product Number

1

Dosage Form

-

Strength

6MG/VIAL

Approval Date

-

19764 / 1

Active Ingredient

SOMATROPIN

Application Number

19764

Product Number

1

Dosage Form

-

Strength

6MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 19764

Drug Name

SAIZEN

Product Number

2

Dosage Form

-

Strength

5MG/VIAL

Approval Date

-

19764 / 2

Active Ingredient

SOMATROPIN

Application Number

19764

Product Number

2

Dosage Form

-

Strength

5MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 19764

Drug Name

SAIZEN

Product Number

3

Dosage Form

-

Strength

8.8MG/VIAL

Approval Date

-

19764 / 3

Active Ingredient

SOMATROPIN

Application Number

19764

Product Number

3

Dosage Form

-

Strength

8.8MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 19764

Drug Name

SAIZEN

Product Number

5

Dosage Form

-

Strength

4MG/VIAL

Approval Date

-

19764 / 5

Active Ingredient

SOMATROPIN

Application Number

19764

Product Number

5

Dosage Form

-

Strength

4MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

1982
22 Mar
Discontinued Application: 18361

Drug Name

SEROPHENE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-03-22

18361 / 1

Active Ingredient

CLOMIPHENE CITRATE

Application Number

18361

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-03-22

Regulatory Status

Discontinued

-
Unclassified Application: 20604

Drug Name

SEROSTIM

Product Number

1

Dosage Form

-

Strength

6MG/VIAL

Approval Date

-

20604 / 1

Active Ingredient

SOMATROPIN

Application Number

20604

Product Number

1

Dosage Form

-

Strength

6MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 20604

Drug Name

SEROSTIM

Product Number

2

Dosage Form

-

Strength

5MG/VIAL

Approval Date

-

20604 / 2

Active Ingredient

SOMATROPIN

Application Number

20604

Product Number

2

Dosage Form

-

Strength

5MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 20604

Drug Name

SEROSTIM

Product Number

3

Dosage Form

-

Strength

4MG/VIAL

Approval Date

-

20604 / 3

Active Ingredient

SOMATROPIN

Application Number

20604

Product Number

3

Dosage Form

-

Strength

4MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 20604

Drug Name

SEROSTIM

Product Number

4

Dosage Form

-

Strength

8.8MG/VIAL

Approval Date

-

20604 / 4

Active Ingredient

SOMATROPIN

Application Number

20604

Product Number

4

Dosage Form

-

Strength

8.8MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 20604

Drug Name

SEROSTIM LQ

Product Number

5

Dosage Form

-

Strength

6MG/0.5ML (6MG/0.5ML)

Approval Date

-

20604 / 5

Active Ingredient

SOMATROPIN

Application Number

20604

Product Number

5

Dosage Form

-

Strength

6MG/0.5ML (6MG/0.5ML)

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 21597

Drug Name

ZORBTIVE

Product Number

1

Dosage Form

-

Strength

4MG/VIAL

Approval Date

-

21597 / 1

Active Ingredient

SOMATROPIN RECOMBINANT

Application Number

21597

Product Number

1

Dosage Form

-

Strength

4MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 21597

Drug Name

ZORBTIVE

Product Number

2

Dosage Form

-

Strength

5MG/VIAL

Approval Date

-

21597 / 2

Active Ingredient

SOMATROPIN RECOMBINANT

Application Number

21597

Product Number

2

Dosage Form

-

Strength

5MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 21597

Drug Name

ZORBTIVE

Product Number

3

Dosage Form

-

Strength

6MG/VIAL

Approval Date

-

21597 / 3

Active Ingredient

SOMATROPIN RECOMBINANT

Application Number

21597

Product Number

3

Dosage Form

-

Strength

6MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 21597

Drug Name

ZORBTIVE

Product Number

4

Dosage Form

-

Strength

8.8MG/VIAL

Approval Date

-

21597 / 4

Active Ingredient

SOMATROPIN RECOMBINANT

Application Number

21597

Product Number

4

Dosage Form

-

Strength

8.8MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

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Drug Status Breakdown
32 total
  • Discontinued
  • 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

GEREF

Application Number

19863

Product Number

1

Active Ingredient

SERMORELIN ACETATE

Dosage Form

-

Strength

EQ 0.05MG BASE/AMP **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FDA Approved Drug Data

Approved drug product information

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