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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Amgen Inc

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01 Ampicillin Sodium (1)

02 Aripiprazole (1)

03 Dexketoprofen Trometamol (1)

04 Etodolac (1)

05 Gemcitabine (1)

06 Granisetron Hydrochloride (1)

07 Ibandronate Sodium (1)

08 Imatinib Mesylate (1)

09 Rocuronium Bromide (1)

10 Sulbactam Sodium (3)

11 Sultamicillin Tosilate Dihydrate (1)

12 Voriconazole (1)

13 Zoledronic Acid (1)

14 Blank (10)

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01 Active (6)

02 Inactive (8)

03 Blank (11)

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01 Blank (25)

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01 Blank (25)

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01 Blank (25)

AMG 191 DRUG SUBSTANCE

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USDMF

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29873
Active
AMG 191 DRUG SUBSTANCE
2015-11-06
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
29873
Status
Active
Fees Unpaid
N/A
 
Filing Details
AMG 191 DRUG SUBSTANCE
Issue/Submission Date
2015-11-06
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AMG 191 CELL LINE DEVELOPMENT

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USDMF

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29877
Active
AMG 191 CELL LINE DEVELOPMENT
2015-11-06
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
29877
Status
Active
Fees Unpaid
N/A
 
Filing Details
AMG 191 CELL LINE DEVELOPMENT
Issue/Submission Date
2015-11-06
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AMG 191 DRUG PRODUCT

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USDMF

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29883
Active
AMG 191 DRUG PRODUCT
2015-11-06
CEP/COS

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Japanese DMF

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Application Number
29883
Status
Active
Fees Unpaid
N/A
 
Filing Details
AMG 191 DRUG PRODUCT
Issue/Submission Date
2015-11-06
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AMG 282 DRUG SUBSTANCE

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USDMF

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30198
Active
AMG 282 DRUG SUBSTANCE
2016-02-22
CEP/COS

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Application Number
30198
Status
Active
Fees Unpaid
N/A
 
Filing Details
AMG 282 DRUG SUBSTANCE
Issue/Submission Date
2016-02-22
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INTRAVENOUS SOLUTION STABILIZER (IVSS)

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USDMF

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31396
Active
INTRAVENOUS SOLUTION STABILIZER (IV...
2017-04-20
CEP/COS

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Japanese DMF

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Application Number
31396
Status
Active
Fees Unpaid
N/A
 
Filing Details
INTRAVENOUS SOLUTION STABILIZER (IV...
Issue/Submission Date
2017-04-20
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AMG 157 (TEZEPELUMAB) PHASE 3 CMC AMENDMENT (DRUG SUBST...

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USDMF

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31671
Active
AMG 157 (TEZEPELUMAB) PHASE 3 CMC A...
2017-08-21
CEP/COS

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Application Number
31671
Status
Active
Fees Unpaid
N/A
 
Filing Details
AMG 157 (TEZEPELUMAB) PHASE 3 CMC A...
Issue/Submission Date
2017-08-21
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USDMF

Caution USDMF

24360
Inactive
STERILE MIXTURE OF AMPICILLIN SODIU...
2010-11-12
CEP/COS

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Application Number
24360
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
STERILE MIXTURE OF AMPICILLIN SODIU...
Issue/Submission Date
2010-11-12
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USDMF

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16587
Inactive
SULBACTAM SODIUM (NON-STERILE)
2003-05-14
CEP/COS

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Application Number
16587
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
SULBACTAM SODIUM (NON-STERILE)
Issue/Submission Date
2003-05-14
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USDMF

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17560
Inactive
SULBACTAM SODIUM (NON-STERILE)
2004-05-26
CEP/COS

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Application Number
17560
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
SULBACTAM SODIUM (NON-STERILE)
Issue/Submission Date
2004-05-26
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USDMF

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22261
Inactive
STERILE SULBACTAM SODIUM
2008-12-04
CEP/COS

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Application Number
22261
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
STERILE SULBACTAM SODIUM
Issue/Submission Date
2008-12-04
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