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01 3Alfentanil Hydrochloride
02 1Ambrisentan
03 2Amphetamine Aspartate
04 4Amphetamine Sulfate
05 1Apomorphine Hydrochloride
06 1Atropine Sulfate
07 1Auranofin
08 1Benzhydrocodone Hydrochloride
09 2Buprenorphine
10 2Buprenorphine Hydrochloride
11 1Calcium Oxybate
12 1Cangrelor
13 1Cannabidiol
14 2Carboplatin
15 1Carmustine
16 1Cisplatin
17 1Clevidipine
18 1Cocaine Hydrochloride
19 1Codeine
20 2Codeine Phosphate
21 1Codeine Sulfate
22 1Decitabine
23 1Dexmethylphenidate
24 2Dextroamphetamine Saccharate
25 1Diamorphine Hydrochloride
26 1Difenoxin Hydrochloride
27 2Dihydrocodeine Hydrogen Tartrate
28 1Dimethyl Fumarate
29 1Diphenoxylate Hydrochloride
30 2Dofetilide
31 1Edrophonium Chloride
32 2Fentanyl
33 2Fentanyl Citrate
34 1Fentanyl Hydrochloride
35 1Hydrocodone Bitartrate
36 3Hydromorphone Hydrochloride
37 1Isoproterenol Hydrochloride
38 1Lenalidomide
39 2Lisdexamfetamine Dimesylate
40 1Lurasidone Hydrochloride
41 1Magnesium Oxybate
42 1Methamphetamine Hydrochloride
43 1Methylphenidate
44 3Methylphenidate Hydrochloride
45 1Miglustat
46 2Morphine Hydrochloride
47 3Morphine Sulfate
48 1Morphine Tartrate
49 1Nabilone
50 2Naloxone Hydrochloride
51 1Nintedanib Esylate
52 1Opium
53 1Oxaliplatin
54 3Oxycodone Hydrochloride
55 1Oxycodone Terephthalate
56 1Oxymorphone Hydrochloride
57 1Pirfenidone
58 3Remifentanil
59 2Sodium Oxybate
60 2Sufentanil Citrate
61 1Umirolimus
62 1Vitamin K1
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01 48Active
02 44Blank
01 23Valid
02 1Withdrawn by Holder
03 68Blank
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01 1218MF11027
02 1222MF10101
03 1222MF10106
04 1223MF10092
05 1302MF10009
06 1307MF10124
07 86Blank
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01 92Blank
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01 120190812-209-J-406
02 120190812-209-J-406(1)
03 120190812-209-J-406(2)
04 120191223-209-J-267
05 120191223-209-J-267(2)
06 120191223-209-J-267(A)
07 120210310-209-J-865
08 120210310-209-J-865(A)
09 120210316-209-J-603
10 120210316-209-J-603(1)
11 120210427-209-J-837
12 120210427-209-J-837(1)
13 120210615-211-J-1028
14 120210615-211-J-1028(A)
15 120210622-210-J-918
16 120210622-210-J-918(A)
17 120220112-210-J-1208
18 120220112-210-J-1208(A)
19 120220204-211-J-1228
20 120220204-211-J-1228(A)
21 120220421-210-J-1273
22 120220421-210-J-1273(A)
23 120220422-210-J-1275
24 120220422-210-J-1275(A)
25 120220422-210-J-1275(B)
26 120251117-209-J-2059
27 1Number 5-1-ND
28 1Number 5-1-ND(1)
29 1Number 5-1-ND(2)
30 63Blank
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01 112707-031
02 112707-035
03 112707-036
04 112707-037
05 149812-0001
06 149812-0004
07 149812-0009
08 249812-0010
09 149812-0011
10 149812-0020
11 149812-0021
12 149812-0026
13 149812-0032
14 149812-0033
15 149812-0051
16 149812-0058
17 149812-0059
18 149812-0060
19 149812-0061
20 149812-0067
21 149812-0075
22 149812-0076
23 149812-0110
24 149812-0124
25 149812-0132
26 149812-0136
27 149812-0141
28 149812-0149
29 149812-0150
30 149812-0156
31 149812-0163
32 149812-0182
33 149812-0183
34 149812-0186
35 149812-0190
36 149812-0195
37 149812-0207
38 149812-0220
39 149812-0232
40 149812-0239
41 149812-0248
42 149812-0255
43 149812-0261
44 149812-0270
45 149812-0295
46 149812-0306
47 149812-0307
48 150137-0686
49 150137-2930
50 150137-3312
51 150137-4051
52 150137-4147
53 150137-4233
54 150137-4237
55 150137-4245
56 36Blank
01 92Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-29
Pay. Date : 2013-10-23
DMF Number : 13188
Submission : 1998-09-11
Status : Active
Type : II
Certificate Number : R1-CEP 2006-237 - Rev 03
Issue Date : 2020-12-16
Type : Chemical
Substance Number : 136
Status : Valid
Registration Number : 223MF10092
Registrant's Address : 10 Wheatfield Road, Edinburgh EH11 2QA, United Kingdom
Initial Date of Registration : 2011-06-29
Latest Date of Registration :
NDC Package Code : 12707-031
Start Marketing Date : 2017-12-14
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-26
Pay. Date : 2012-11-30
DMF Number : 19109
Submission : 2006-01-12
Status : Active
Type : II
Certificate Number : R1-CEP 2002-168 - Rev 07
Issue Date : 2019-09-25
Type : Chemical
Substance Number : 1181
Status : Valid
Registration Number : 218MF11027
Registrant's Address : 10 Wheatfield Road, Edinburgh EH11 2QA, United Kingdom
Initial Date of Registration : 2006-12-28
Latest Date of Registration :
NDC Package Code : 12707-035
Start Marketing Date : 2017-12-14
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
| Available Reg. Filing : ROW |
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-13
Pay. Date : 2015-02-02
DMF Number : 7145
Submission : 1987-09-17
Status : Active
Type : II
Certificate Number : R1-CEP 2004-104 - Rev 03
Issue Date : 2023-03-27
Type : Chemical
Substance Number : 1081
Status : Valid
Registration Number : 222MF10101
Registrant's Address : 25 Patton Road, Devens, MA 01434 USA
Initial Date of Registration : 2010-03-18
Latest Date of Registration :
NDC Package Code : 49812-0010
Start Marketing Date : 2014-01-14
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg. Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9601
Submission : 1992-03-26
Status : Active
Type : II
Certificate Number : CEP 2005-253 - Rev 02
Issue Date : 2025-01-22
Type : Chemical
Substance Number : 599
Status : Valid
Registration Number : 222MF10106
Registrant's Address : 435 Devon Park Drive, Suite 400, Wayne, Pennsylvania 19087 USA
Initial Date of Registration : 2010-03-19
Latest Date of Registration :
NDC Package Code : 49812-0009
Start Marketing Date : 1985-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10137
Submission : 1993-03-05
Status : Active
Type : II
Certificate Number : CEP 2017-119 - Rev 02
Issue Date : 2026-03-03
Type : Chemical
Substance Number : 2235
Status : Valid
Registration Number : 307MF10124
Registrant's Address : 10 Wheatfield Road, Edinburgh EH11 2QA, United Kingdom
Initial Date of Registration : 2025-10-08
Latest Date of Registration :
NDC Package Code : 49812-0020
Start Marketing Date : 2010-06-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Myungin Pharmaceutical Co., Ltd.
Registration Date : 2025-11-17
Registration Number : 20251117-209-J-2059
Manufacturer Name : Macfarlan Smith Limited
Manufacturer Address : 10, Wheatfield Road, Edinburgh EH11 2QA, United Kingdom
| Available Reg. Filing : ROW |
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-31
Pay. Date : 2013-01-07
DMF Number : 19547
Submission : 2006-06-26
Status : Active
Type : II
Certificate Number : R1-CEP 2009-078 - Rev 00
Issue Date : 2015-01-27
Type : Chemical
Substance Number : 2235
Status : Valid
Registration Number : 302MF10009
Registrant's Address : 10 Wheatfield Road, Edinburgh EH11 2QA, United Kingdom
Initial Date of Registration : 2020-01-17
Latest Date of Registration :
Registrant Name : Whanin Pharmaceutical Co., Ltd.
Registration Date : 2021-12-17
Registration Number : 20210427-209-J-837(1)
Manufacturer Name : Macfarlan Smith Limited@Macfarlan Smith Limited
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom@Three Trees Road, Newbie, Annan, DG12 5QH, United Kingdom
| Available Reg. Filing : ROW |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12661
Submission : 1997-09-19
Status : Active
Type : II
Certificate Number : R1-CEP 2011-195 - Rev 02
Issue Date : 2023-08-30
Type : Chemical
Substance Number : 1062
Status : Valid
NDC Package Code : 49812-0033
Start Marketing Date : 1997-09-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Nosa Chemical Co., Ltd.
Registration Date : 2022-08-29
Registration Number : 20220422-210-J-1275(B)
Manufacturer Name : Macfarlan Smith Limited
Manufacturer Address : 10, Wheatfield Road, Edinburgh EH11 2QA, Scotland, UK
| Available Reg. Filing : ROW |
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-08
Pay. Date : 2012-12-12
DMF Number : 26448
Submission : 2012-09-17
Status : Active
Type : II
Certificate Number : R1-CEP 2006-009 - Rev 04
Issue Date : 2019-12-11
Type : Chemical
Substance Number : 1180
Status : Valid
NDC Package Code : 12707-036
Start Marketing Date : 2017-12-11
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT FOR ...
| Available Reg. Filing : ROW |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20787
Submission : 2007-08-23
Status : Active
Type : II
Certificate Number : R1-CEP 1999-053 - Rev 03
Issue Date : 2014-12-19
Type : Chemical
Substance Number : 74
Status : Valid
NDC Package Code : 49812-0051
Start Marketing Date : 2019-09-06
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Samung Industry Co., Ltd.
Registration Date : 2021-03-16
Registration Number : 20210316-209-J-603
Manufacturer Name : Macfarlan Smith Limited@Macfarlan Smith Limited@Tasmanian Alkaloids Pty Limited
Manufacturer Address : Three Trees Road Newbie, Annan DG12 5QH United Kingdom@10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom@160 Birralee Road, Westbury, Tasmania, 7303, Australia
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-18
Pay. Date : 2012-12-13
DMF Number : 6217
Submission : 1986-02-25
Status : Active
Type : II
Certificate Number : CEP 2000-141 - Rev 04
Issue Date : 2026-01-19
Type : Chemical
Substance Number : 1210
Status : Valid
NDC Package Code : 49812-0004
Start Marketing Date : 1985-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samung Industry Co., Ltd.
Registration Date : 2021-08-26
Registration Number : 20210615-211-J-1028(A)
Manufacturer Name : Macfarlan Smith Limited
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom
| Available Reg. Filing : ROW |
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