EMD Serono Unclassified
FDA Approved Drugs

EMD Serono Unclassified

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.

Unclassified
  • Total Records 27
  • Latest Approval Date -
  • Data Source FDA
  • First Approval Date -
All
32
View
Unclassified
27
View
Discontinued
5
View
Company Overview

Company

EMD Serono Unclassified

Country

U.S.A

Website

Visit Website

Email

Social Profiles

LinkedIn X / Twitter
Company Snapshot

EMD Serono Unclassified

One Technology Place, Rockland, MA 02370

U.S.A

www.emdserono.com/us-en?global_redirect=1 View on Map
FDA Approved Drug Records ( 27 records )
-
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

-
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

-
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
27 total
  • 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

GONAL-F

Application Number

20378

Product Number

1

Active Ingredient

FOLLITROPIN ALFA/BETA

Dosage Form

-

Strength

75 IU/VIAL

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

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