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01 1Amphetamine Sulfate
02 1Apomorphine Hydrochloride
03 1Buprenorphine
04 2Buprenorphine Hydrochloride
05 1Codeine Phosphate
06 1Ethylmorphine Hydrochloride
07 1Hydrocodone Bitartrate
08 1Hydromorphone Hydrochloride
09 1Lisdexamfetamine Dimesylate
10 1Pramipexole Dihydrochloride
11 1Remifentanil
12 1Risedronate Sodium
13 1Terbinafine Hydrochloride
14 1Tolfenamic Acid
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01 2Active
02 13Blank
01 1Expired
02 7Valid
03 7Blank
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01 15Blank
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01 15Blank
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01 182274-001
02 14Blank
01 15Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-11-15
Pay. Date : 2021-07-14
DMF Number : 35988
Submission : 2021-07-30
Status : Active
Type : II
Certificate Number : R0-CEP 2020-339 - Rev 01
Issue Date : 2022-06-21
Type : Chemical
Substance Number : 1181
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22869
Submission : 2009-06-12
Status : Active
Type : II
Certificate Number : R1-CEP 2010-174 - Rev 01
Issue Date : 2020-04-09
Type : Chemical
Substance Number : 2416
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2019-097 - Rev 01
Issue Date : 2025-01-03
Type : Chemical
Substance Number : 2752
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R0-CEP 2021-098 - Rev 00
Issue Date : 2022-11-14
Type : Chemical
Substance Number : 1180
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2010-117 - Rev 02
Issue Date : 2022-08-04
Type : Chemical
Substance Number : 2099
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2010-156 - Rev 02
Issue Date : 2019-05-15
Type : Chemical
Substance Number : 1734
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R0-CEP 2020-004 - Rev 00
Issue Date : 2021-07-16
Type : Chemical
Substance Number : 2039
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R0-CEP 2017-232 - Rev 00
Issue Date : 2019-03-13
Type : Chemical
Substance Number : 74
Status : Expired

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 82274-001
Start Marketing Date : 2024-12-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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