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

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01 Buprenorphine (2)

02 Buprenorphine Hydrochloride (2)

03 Cannabidiol (2)

04 Codeine Phosphate (1)

05 Dexmethylphenidate (1)

06 Hydrocodone Bitartrate (2)

07 Hydromorphone Hydrochloride (1)

08 Levorphanol Tartrate (1)

09 Lisdexamfetamine Dimesylate (1)

10 Methylnaltrexone Bromide (1)

11 Methylphenidate Hydrochloride (3)

12 Morphine Sulfate (2)

13 Nabilone (2)

14 Naloxone Hydrochloride (2)

15 Naltrexone (1)

16 Naltrexone Hydrochloride (1)

17 Oxycodone Hydrochloride (3)

18 Oxymorphone (1)

19 Oxymorphone Hydrochloride (1)

20 Psilocybine (1)

21 Sodium Oxybate (1)

22 Tapentadol (1)

23 Tetrahydrocannabinol (4)

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01 Active (31)

02 Blank (6)

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01 Valid (9)

02 Blank (28)

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01 Blank (37)

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01 Blank (37)

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USDMF

Found USDMF

23684
Active
BUPRENORPHINE BASE (R371605) DRUG S...
2010-04-05
CEP/COS

Found CEP/COS

R1-CEP 2007-190 - Rev 04
Valid
Buprenorphine
2022-12-07
Japanese DMF

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Written Confirmation

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Application Number
23684
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
BUPRENORPHINE BASE (R371605) DRUG S...
Buprenorphine
Issue/Submission Date
2010-04-05
2022-12-07
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USDMF

Found USDMF

23683
Active
BUPRENORPHINE HYDROCHLORIDE (R03686...
2010-04-05
CEP/COS

Found CEP/COS

R1-CEP 2010-142 - Rev 05
Valid
Buprenorphine hydrochloride
2023-08-23
Japanese DMF

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Written Confirmation

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Application Number
23683
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
BUPRENORPHINE HYDROCHLORIDE (R03686...
Buprenorphine hydrochloride
Issue/Submission Date
2010-04-05
2023-08-23
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USDMF

Found USDMF

19561
Active
HYDROMORPHONE HYDROCHLORIDE DRUG SU...
2006-06-29
CEP/COS

Found CEP/COS

R1-CEP 2006-169 - Rev 04
Valid
Hydromorphone hydrochloride
2021-03-25
Japanese DMF

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Written Confirmation

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Application Number
19561
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
HYDROMORPHONE HYDROCHLORIDE DRUG SU...
Hydromorphone hydrochloride
Issue/Submission Date
2006-06-29
2021-03-25
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USDMF

Found USDMF

22244
Active
METHYLPHENIDATE HYDROCHLORIDE
2008-12-19
CEP/COS

Found CEP/COS

R0-CEP 2018-030 - Rev 03
Valid
Methylphenidate hydrochloride
2022-10-26
Japanese DMF

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Written Confirmation

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Application Number
22244
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate hydrochloride
Issue/Submission Date
2008-12-19
2022-10-26
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USDMF

Found USDMF

24633
Active
NALOXONE HYDROCHLORIDE DRUG SUBSTAN...
2011-02-15
CEP/COS

Found CEP/COS

CEP 2011-055 - Rev 03
Valid
Naloxone hydrochloride dihydrate
2023-09-06
Japanese DMF

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Written Confirmation

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Application Number
24633
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
NALOXONE HYDROCHLORIDE DRUG SUBSTAN...
Naloxone hydrochloride dihydrate
Issue/Submission Date
2011-02-15
2023-09-06
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USDMF

Found USDMF

28226
Active
NALOXONE HCl DIHYDRATE, USP
2014-08-13
CEP/COS

Found CEP/COS

R1-CEP 2014-125 - Rev 01
Valid
Naloxone hydrochloride dihydrate
2021-02-24
Japanese DMF

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Written Confirmation

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Application Number
28226
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
NALOXONE HCl DIHYDRATE, USP
Naloxone hydrochloride dihydrate
Issue/Submission Date
2014-08-13
2021-02-24
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USDMF

Found USDMF

23325
Active
NALTREXONE HYDROCHLORIDE DRUG SUBST...
2009-12-01
CEP/COS

Found CEP/COS

R0-CEP 2020-291 - Rev 01
Valid
Naltrexone hydrochloride, Wavelengt...
2022-03-17
Japanese DMF

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Written Confirmation

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Application Number
23325
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
NALTREXONE HYDROCHLORIDE DRUG SUBST...
Naltrexone hydrochloride, Wavelengt...
Issue/Submission Date
2009-12-01
2022-03-17
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USDMF

Found USDMF

16399
Active
OXYCODONE HYDROCHLORIDE
2003-02-03
CEP/COS

Found CEP/COS

R1-CEP 2009-058 - Rev 04
Valid
Oxycodone hydrochloride
2022-05-12
Japanese DMF

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Written Confirmation

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Application Number
16399
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
OXYCODONE HYDROCHLORIDE
Oxycodone hydrochloride
Issue/Submission Date
2003-02-03
2022-05-12
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USDMF

Found USDMF

20975
Active
OXYCODONE HYDROCHLORIDE DRUG SUBSTA...
2007-10-26
CEP/COS

Found CEP/COS

R1-CEP 2011-284 - Rev 02
Valid
Oxycodone hydrochloride
2021-02-24
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
20975
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
OXYCODONE HYDROCHLORIDE DRUG SUBSTA...
Oxycodone hydrochloride
Issue/Submission Date
2007-10-26
2021-02-24
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USDMF

Found USDMF

30762
Active
BUPRENORPHINE
2016-08-04
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

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Application Number
30762
Status
Active
Fees Paid
Reviewed
 
Filing Details
BUPRENORPHINE
Issue/Submission Date
2016-08-04
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