01 1Alembic Pharmaceuticals Limited
02 2Boehringer Ingelheim GmbH
03 1CSPC New Nova Pharmaceutical
04 3Concordia Labs Inc
05 8F. Hoffmann-La Roche
06 1Hainan Poly Pharm
07 1Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd
08 3Mallinckrodt Pharmaceuticals
09 1Roche Diagnostics GmbH
10 1Shandong Xinhua Pharmaceutical
11 2Siegfried AG
12 1The Dow Chemical Company
13 12Blank
01 17 BETA-HYDROXYPROPYL THEOPHYLLINE
02 18 - BROMOTHEOPHYLLINE
03 1ACCURBRON, S.R. (CONTROLLED RELEASE THEOPHYLLINE)
04 1AEROLATE CONTROLLED-RELEASE CAPSULES CONTAINING THEOPHYLLINE
05 1DIHYDROXYPROPYL-THEOPHYLLIN
06 1DIHYDROXYPROPYLTHEOPHYLLINE (DYPHYLLINE)
07 1ELIXOPHYLLIN SUSTAINED RELEASE CAPSULES 125MG (THEOPHYLLINE)
08 1ELIXOPHYLLIN SUSTAINED RELEASE CAPSULES 250MG. (THEOPHYLLINE)
09 1PAMABROM (8-BROMOTHEOPHYLLINE-ISOBUTANOLAMINE)
10 1SOMOPHYLLIN CONTROLLED RELEASE THEOPHYLLINE 250MG
11 1THEOPHILLINE S.R. CAPSULES 250MG
12 1THEOPHYL S.R. CAPS 125MG & 250MG (THEOPHYLLINE)-FOR KNOLL PHARMA CO.
13 1THEOPHYLLIN
14 4THEOPHYLLINE
15 1THEOPHYLLINE (ANHYDROUS)
16 1THEOPHYLLINE (ANHYDROUS) USP
17 1THEOPHYLLINE ANHYDROUS
18 1THEOPHYLLINE CAP
19 1THEOPHYLLINE CAPS., 250MG
20 1THEOPHYLLINE CAPSULES, T.D.
21 2THEOPHYLLINE CONTROLLED RELEASE BEADS
22 1THEOPHYLLINE EXTENDED RELEASE CAPSULES
23 1THEOPHYLLINE HYDROUS
24 1THEOPHYLLINE MONOHYDRATE
25 1THEOPHYLLINE PHARMAZOME TM POWDER
26 1THEOPHYLLINE R 85 D/02
27 1THEOPHYLLINE S.R. CAPS 300MG
28 1THEOPHYLLINE S.R. CAPSULES 125MG
29 1THEOPHYLLINE S.R. CAPSULES, 250 MG.
30 1THEOPHYLLINE SR62.5MG MNFG IN ST.LOUIS,MO FOR SCHERING,KENILWORTH N.J.
31 1THEOPHYLLINE SUSTAINED RELEASE CAPSULES (BY-158)
32 1THEOPHYLLINE SUSTAINED RELEASE CAPSULES, 125 MG.
33 1THEOPHYLLINE, ANHYDROUS
01 3Canada
02 4China
03 3Germany
04 1India
05 3Ireland
06 10Switzerland
07 1U.S.A
08 12Blank
01 4Active
02 33Inactive
01 1Complete
02 36Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35365
Submission : 2020-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2730
Submission : 1976-08-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3040
Submission : 1977-10-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2864
Submission : 1977-02-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4633
Submission : 1982-07-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20455
Submission : 2007-04-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-04
Pay. Date : 2013-08-27
DMF Number : 4097
Submission : 1981-02-24
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2298
Submission : 1974-07-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1911
Submission : 1972-04-04
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 539
Submission : 1963-04-25
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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