Amgen Inc Unclassified
FDA Approved Drugs

Amgen Inc 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 50
  • Latest Approval Date -
  • Data Source FDA
  • First Approval Date -
All
66
View
Unclassified
50
View
Discontinued
8
View
RX
8
View
Company Overview

Company

Amgen Inc Unclassified

Country

U.S.A

Website

Visit Website

Email

amgenfoundation@amgen.com

Social Profiles

Company Snapshot

Amgen Inc Unclassified

One Amgen Center Drive, Thousand Oaks, CA91320-1799

U.S.A

www.amgen.com/ amgenfoundation@amgen.com View on Map
FDA Approved Drug Records ( 50 records )
-
Unclassified Application: 761077

Drug Name

AIMOVIG

Product Number

1

Dosage Form

-

Strength

70MG/ML

Approval Date

-

761077 / 1

Active Ingredient

ERENUMAB-AOOE

Application Number

761077

Product Number

1

Dosage Form

-

Strength

70MG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761024

Drug Name

AMJEVITA

Product Number

1

Dosage Form

-

Strength

20MG/0.4ML

Approval Date

-

761024 / 1

Active Ingredient

ADALIMUMAB-ATTO

Application Number

761024

Product Number

1

Dosage Form

-

Strength

20MG/0.4ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761024

Drug Name

AMJEVITA

Product Number

2

Dosage Form

-

Strength

40MG/0.8ML

Approval Date

-

761024 / 2

Active Ingredient

ADALIMUMAB-ATTO

Application Number

761024

Product Number

2

Dosage Form

-

Strength

40MG/0.8ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103951

Drug Name

ARANESP

Product Number

1

Dosage Form

-

Strength

25UG/ML

Approval Date

-

103951 / 1

Active Ingredient

DARBEPOETIN ALFA

Application Number

103951

Product Number

1

Dosage Form

-

Strength

25UG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103951

Drug Name

ARANESP

Product Number

2

Dosage Form

-

Strength

40UG/ML

Approval Date

-

103951 / 2

Active Ingredient

DARBEPOETIN ALFA

Application Number

103951

Product Number

2

Dosage Form

-

Strength

40UG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103951

Drug Name

ARANESP

Product Number

3

Dosage Form

-

Strength

60UG/ML

Approval Date

-

103951 / 3

Active Ingredient

DARBEPOETIN ALFA

Application Number

103951

Product Number

3

Dosage Form

-

Strength

60UG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103951

Drug Name

ARANESP

Product Number

4

Dosage Form

-

Strength

100UG/ML

Approval Date

-

103951 / 4

Active Ingredient

DARBEPOETIN ALFA

Application Number

103951

Product Number

4

Dosage Form

-

Strength

100UG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103951

Drug Name

ARANESP

Product Number

5

Dosage Form

-

Strength

200UG/ML

Approval Date

-

103951 / 5

Active Ingredient

DARBEPOETIN ALFA

Application Number

103951

Product Number

5

Dosage Form

-

Strength

200UG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103951

Drug Name

ARANESP

Product Number

6

Dosage Form

-

Strength

25UG/ML

Approval Date

-

103951 / 6

Active Ingredient

DARBEPOETIN ALFA

Application Number

103951

Product Number

6

Dosage Form

-

Strength

25UG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103951

Drug Name

ARANESP

Product Number

7

Dosage Form

-

Strength

40UG/ML

Approval Date

-

103951 / 7

Active Ingredient

DARBEPOETIN ALFA

Application Number

103951

Product Number

7

Dosage Form

-

Strength

40UG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103951

Drug Name

ARANESP

Product Number

8

Dosage Form

-

Strength

60UG/ML

Approval Date

-

103951 / 8

Active Ingredient

DARBEPOETIN ALFA

Application Number

103951

Product Number

8

Dosage Form

-

Strength

60UG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103951

Drug Name

ARANESP

Product Number

9

Dosage Form

-

Strength

100UG/ML

Approval Date

-

103951 / 9

Active Ingredient

DARBEPOETIN ALFA

Application Number

103951

Product Number

9

Dosage Form

-

Strength

100UG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103951

Drug Name

ARANESP

Product Number

10

Dosage Form

-

Strength

200UG/ML

Approval Date

-

103951 / 10

Active Ingredient

DARBEPOETIN ALFA

Application Number

103951

Product Number

10

Dosage Form

-

Strength

200UG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761086

Drug Name

AVSOLA

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

-

761086 / 1

Active Ingredient

INFLIXIMAB-AXXQ

Application Number

761086

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761333

Drug Name

BKEMV

Product Number

1

Dosage Form

-

Strength

300MG/30ML(10MG/ML)

Approval Date

-

761333 / 1

Active Ingredient

ECULIZUMAB-AEEB

Application Number

761333

Product Number

1

Dosage Form

-

Strength

300MG/30ML(10MG/ML)

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 125557

Drug Name

BLINCYTO

Product Number

1

Dosage Form

-

Strength

35MCG

Approval Date

-

125557 / 1

Active Ingredient

BLINATUMOMAB

Application Number

125557

Product Number

1

Dosage Form

-

Strength

35MCG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103234

Drug Name

EPOGEN/PROCRIT

Product Number

1

Dosage Form

-

Strength

10,000U/ML

Approval Date

-

103234 / 1

Active Ingredient

EPOETIN ALFA

Application Number

103234

Product Number

1

Dosage Form

-

Strength

10,000U/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103234

Drug Name

EPOGEN/PROCRIT

Product Number

2

Dosage Form

-

Strength

20,000U/2ML

Approval Date

-

103234 / 2

Active Ingredient

EPOETIN ALFA

Application Number

103234

Product Number

2

Dosage Form

-

Strength

20,000U/2ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103234

Drug Name

EPOGEN/PROCRIT

Product Number

3

Dosage Form

-

Strength

20,000/ML

Approval Date

-

103234 / 3

Active Ingredient

EPOETIN ALFA

Application Number

103234

Product Number

3

Dosage Form

-

Strength

20,000/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103234

Drug Name

EPOGEN/PROCRIT

Product Number

4

Dosage Form

-

Strength

2,000U/ML

Approval Date

-

103234 / 4

Active Ingredient

EPOETIN ALFA

Application Number

103234

Product Number

4

Dosage Form

-

Strength

2,000U/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103234

Drug Name

EPOGEN/PROCRIT

Product Number

5

Dosage Form

-

Strength

3,000U/ML

Approval Date

-

103234 / 5

Active Ingredient

EPOETIN ALFA

Application Number

103234

Product Number

5

Dosage Form

-

Strength

3,000U/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103234

Drug Name

EPOGEN/PROCRIT

Product Number

6

Dosage Form

-

Strength

40,000U/ML

Approval Date

-

103234 / 6

Active Ingredient

EPOETIN ALFA

Application Number

103234

Product Number

6

Dosage Form

-

Strength

40,000U/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103234

Drug Name

EPOGEN/PROCRIT

Product Number

7

Dosage Form

-

Strength

4,000U/ML

Approval Date

-

103234 / 7

Active Ingredient

EPOETIN ALFA

Application Number

103234

Product Number

7

Dosage Form

-

Strength

4,000U/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761062

Drug Name

EVENITY

Product Number

1

Dosage Form

-

Strength

105MG/1.17ML

Approval Date

-

761062 / 1

Active Ingredient

ROMOSOZUMAB-AQQG

Application Number

761062

Product Number

1

Dosage Form

-

Strength

105MG/1.17ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761344

Drug Name

IMDELLTRA

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

-

761344 / 1

Active Ingredient

TARLATAMAB-DLLE

Application Number

761344

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761344

Drug Name

IMDELLTRA

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

761344 / 2

Active Ingredient

TARLATAMAB-DLLE

Application Number

761344

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761073

Drug Name

KANJINTI

Product Number

1

Dosage Form

-

Strength

420MG

Approval Date

-

761073 / 1

Active Ingredient

TRASTUZUMAB-ANNS

Application Number

761073

Product Number

1

Dosage Form

-

Strength

420MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761073

Drug Name

KANJINTI

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

-

761073 / 2

Active Ingredient

TRASTUZUMAB-ANNS

Application Number

761073

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761028

Drug Name

MVASI

Product Number

1

Dosage Form

-

Strength

100MG/4ML (25MG/ML)

Approval Date

-

761028 / 1

Active Ingredient

BEVACIZUMAB-AWWB

Application Number

761028

Product Number

1

Dosage Form

-

Strength

100MG/4ML (25MG/ML)

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761028

Drug Name

MVASI

Product Number

2

Dosage Form

-

Strength

400MG/16ML (25MG/ML)

Approval Date

-

761028 / 2

Active Ingredient

BEVACIZUMAB-AWWB

Application Number

761028

Product Number

2

Dosage Form

-

Strength

400MG/16ML (25MG/ML)

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 125031

Drug Name

NEULASTA

Product Number

1

Dosage Form

-

Strength

6MG/0.6ML

Approval Date

-

125031 / 1

Active Ingredient

PEGFILGRASTIM

Application Number

125031

Product Number

1

Dosage Form

-

Strength

6MG/0.6ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103353

Drug Name

NEUPOGEN

Product Number

1

Dosage Form

-

Strength

300MCG/1ML

Approval Date

-

103353 / 1

Active Ingredient

FILGRASTIM

Application Number

103353

Product Number

1

Dosage Form

-

Strength

300MCG/1ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103353

Drug Name

NEUPOGEN

Product Number

2

Dosage Form

-

Strength

480MCG/1.6ML

Approval Date

-

103353 / 2

Active Ingredient

FILGRASTIM

Application Number

103353

Product Number

2

Dosage Form

-

Strength

480MCG/1.6ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103353

Drug Name

NEUPOGEN

Product Number

3

Dosage Form

-

Strength

300MGC/0.5ML

Approval Date

-

103353 / 3

Active Ingredient

FILGRASTIM

Application Number

103353

Product Number

3

Dosage Form

-

Strength

300MGC/0.5ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103353

Drug Name

NEUPOGEN

Product Number

4

Dosage Form

-

Strength

480MCG/0.8ML

Approval Date

-

103353 / 4

Active Ingredient

FILGRASTIM

Application Number

103353

Product Number

4

Dosage Form

-

Strength

480MCG/0.8ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 125268

Drug Name

NPLATE

Product Number

1

Dosage Form

-

Strength

250MCG/0.5ML; 500MCG/1ML.

Approval Date

-

125268 / 1

Active Ingredient

ROMIPLOSTIM

Application Number

125268

Product Number

1

Dosage Form

-

Strength

250MCG/0.5ML; 500MCG/1ML.

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 210745

Drug Name

OTEZLA

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

210745 / 2

Active Ingredient

APREMILAST

Application Number

210745

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 210745

Drug Name

OTEZLA

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

-

210745 / 3

Active Ingredient

APREMILAST

Application Number

210745

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 210745

Drug Name

OTEZLA

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

-

210745 / 5

Active Ingredient

APREMILAST

Application Number

210745

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761298

Drug Name

PAVBLU

Product Number

1

Dosage Form

-

Strength

2 mg (0.05 mL of 40 mg/mL)

Approval Date

-

761298 / 1

Active Ingredient

AFLIBERCEPT-AYYH

Application Number

761298

Product Number

1

Dosage Form

-

Strength

2 mg (0.05 mL of 40 mg/mL)

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 125320

Drug Name

PROLIA

Product Number

1

Dosage Form

-

Strength

60MG/ML

Approval Date

-

125320 / 1

Active Ingredient

DENOSUMAB

Application Number

125320

Product Number

1

Dosage Form

-

Strength

60MG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 125522

Drug Name

REPATHA

Product Number

1

Dosage Form

-

Strength

140MG/ML

Approval Date

-

125522 / 1

Active Ingredient

EVOLOCUMAB

Application Number

125522

Product Number

1

Dosage Form

-

Strength

140MG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761140

Drug Name

RIABNI

Product Number

1

Dosage Form

-

Strength

100MG/10ML(10MG/ML)

Approval Date

-

761140 / 1

Active Ingredient

RITUXIMAB-ARRX

Application Number

761140

Product Number

1

Dosage Form

-

Strength

100MG/10ML(10MG/ML)

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 125147

Drug Name

VECTIBIX

Product Number

1

Dosage Form

-

Strength

5ML/100MG

Approval Date

-

125147 / 1

Active Ingredient

PANITUMUMAB

Application Number

125147

Product Number

1

Dosage Form

-

Strength

5ML/100MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 125147

Drug Name

VECTIBIX

Product Number

2

Dosage Form

-

Strength

10ML/200MG

Approval Date

-

125147 / 2

Active Ingredient

PANITUMUMAB

Application Number

125147

Product Number

2

Dosage Form

-

Strength

10ML/200MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 125147

Drug Name

VECTIBIX

Product Number

3

Dosage Form

-

Strength

20ML/400MG

Approval Date

-

125147 / 3

Active Ingredient

PANITUMUMAB

Application Number

125147

Product Number

3

Dosage Form

-

Strength

20ML/400MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761285

Drug Name

WEZLANA

Product Number

1

Dosage Form

-

Strength

45MG/0.5ML

Approval Date

-

761285 / 1

Active Ingredient

USTEKINUMAB-AUUB

Application Number

761285

Product Number

1

Dosage Form

-

Strength

45MG/0.5ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761285

Drug Name

WEZLANA

Product Number

2

Dosage Form

-

Strength

90MG/ML

Approval Date

-

761285 / 2

Active Ingredient

USTEKINUMAB-AUUB

Application Number

761285

Product Number

2

Dosage Form

-

Strength

90MG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761331

Drug Name

WEZLANA

Product Number

1

Dosage Form

-

Strength

130MG/26ML

Approval Date

-

761331 / 1

Active Ingredient

USTEKINUMAB-AUUB

Application Number

761331

Product Number

1

Dosage Form

-

Strength

130MG/26ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 125320

Drug Name

XGEVA

Product Number

2

Dosage Form

-

Strength

70MG/ML

Approval Date

-

125320 / 2

Active Ingredient

DENOSUMAB

Application Number

125320

Product Number

2

Dosage Form

-

Strength

70MG/ML

Approval Date

-

Regulatory Status

Unclassified

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Drug Status Breakdown
50 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

AIMOVIG

Application Number

761077

Product Number

1

Active Ingredient

ERENUMAB-AOOE

Dosage Form

-

Strength

70MG/ML

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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