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01 1ABROCITINIB
02 1ACEBUTOLOL
03 1ACETYLCYSTEINE USP
04 1AMANTADINE HYDROCHLORIDE
05 1AMLODIPINE BESILATE
06 1ARTICAINE HCL
07 1BISOPROLOL FUMARATE
08 1BUPIVACAINE HYDROCHLORIDE
09 1BUTALBITAL
10 1CARVEDILOL
11 1CELIPROLOL HYDROCHLORIDE
12 1CHOLINE FENOFIBRATE
13 2DEXMEDETOMIDINE HYDROCHLORIDE
14 1DULOXETINE HYDROCHLORIDE
15 1ELAGOLIX SODIUM
16 1FENOFIBRATE
17 1FEZOLINETANT
18 1HYDROXYZINE HYDROCHLORIDE
19 1LANSOPRAZOLE
20 1LASMIDITAN HEMISUCCINATE
21 1LEMBOREXANT
22 1LIDOCAINE
23 1LIDOCAINE HYDROCHLORIDE
24 1MAVACAMTEN
25 1MEPIVACAINE HYDROCHLORIDE
26 1METHENAMINE HIPPURATE
27 1METOPROLOL SUCCINATE
28 1METOPROLOL TARTRATE
29 1MICRONIZED FENOFIBRATE & FENOFIBRATE
30 1NIFEDIPINE
31 1OBETICHOLIC ACID
32 1PANTOPRAZOLE SODIUM SESQUIHYDRATE
33 1PHENTERMINE HYDROCHLORIDE USP
34 1PRILOCAINE
35 1PRILOCAINE HYDROCHLORIDE
36 1PROPYLTHIOURACIL USP
37 1QUETIAPINE FUMARATE
38 1RABEPRAZOLE SODIUM
39 1RELUGOLIX
40 1REMIMAZOLAM BESYLATE
41 1RIMEGEPANT SULFATE
42 1ROPIVACAINE HYDROCHLORIDE
43 1SITAGLIPTIN BASE
44 1SITAGLIPTIN PHOSPHATE MONOHYDRATE
45 1SOTALOL HCI
46 1SUMATRIPTAN
47 1SUMATRIPTAN SUCCINATE
48 1TIRBANIBULIN
49 1TRIAMTERENE
50 1VENLAFAXINE HYDROCHLORIDE
51 1VERICIGUAT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38879
Submission : 2023-09-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-10-05
Pay. Date : 2020-09-29
DMF Number : 14420
Submission : 1999-09-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-22
Pay. Date : 2013-01-07
DMF Number : 14304
Submission : 1999-07-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-16
Pay. Date : 2014-05-13
DMF Number : 6924
Submission : 1987-04-08
Status : Active
Type : II
KEY PRODUCTS
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
