01 1PROMIUS PHARMA
02 1SKYEPHARMA AG
03 3STRIDES PHARMA
04 3ACCORD HLTHCARE
05 2ACTAVIS ELIZABETH
06 1ALKERMES GAINESVILLE
07 1ANI PHARMS
08 3AUROBINDO PHARMA
09 3CHARTWELL MOLECULAR
10 3DEXCEL LTD
11 2GENUS
12 2HIKMA INTL PHARMS
13 1HIKMA PHARMS
14 3IVAX SUB TEVA PHARMS
15 2OMNIVIUM PHARMS
16 3RICONPHARMA LLC
17 3SCHERING PLOUGH
18 3SHANDONG
19 3TORRENT PHARMS
20 3ZYDUS HLTHCARE
21 3ZYDUS PHARMS
01 42TABLET, EXTENDED RELEASE;ORAL
02 7TABLET;ORAL
01 24DISCN
02 25RX
01 3IMDUR
02 1ISMO
03 43ISOSORBIDE MONONITRATE
04 2MONOKET
01 44No
02 5Yes
RLD : No
TE Code :
Brand Name : ISMO
Dosage Form : TABLET;ORAL
Dosage Strength : 20MG
Approval Date : 1991-12-30
Application Number : 19091
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Skyepharma, an Expert and Innovative CDMO Partner for tailor-made solutions in complex oral solids and bioproduction.
RLD : No
TE Code :
Brand Name : ISOSORBIDE MONONITRATE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 60MG
Approval Date : 1999-10-07
Application Number : 75166
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
RLD : No
TE Code :
Brand Name : ISOSORBIDE MONONITRATE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 30MG
Approval Date : 2010-08-11
Application Number : 90598
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
RLD : No
TE Code :
Brand Name : ISOSORBIDE MONONITRATE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 60MG
Approval Date : 2010-08-11
Application Number : 90598
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
RLD : No
TE Code :
Brand Name : ISOSORBIDE MONONITRATE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 120MG
Approval Date : 2010-08-11
Application Number : 90598
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : IMDUR
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1993-08-12
Application Number : 20225
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : IMDUR
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1993-08-12
Application Number : 20225
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : IMDUR
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1995-03-30
Application Number : 20225
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code : AB
Brand Name : MONOKET
Dosage Form : TABLET;ORAL
Dosage Strength : 20MG
Approval Date : 1993-06-30
Application Number : 20215
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
Brand Name : MONOKET
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Approval Date : 1993-06-30
Application Number : 20215
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
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