01 2ALLERGAN
02 2LGM PHARMA
03 3STRIDES PHARMA
04 1ABHAI LLC
05 1AMNEAL PHARMS CO
06 1AUROBINDO PHARMA LTD
07 1CHARTWELL RX
08 2ENDO OPERATIONS
09 1EPIC PHARMA
10 2EPIC PHARMA LLC
11 2GLENMARK PHARMS LTD
12 1HIBROW HLTHCARE
13 3IMPAX LABS INC
14 1LANNETT CO INC
15 1NORVIUM BIOSCIENCE
16 1RISING
17 1RK PHARMA
18 2TEVA BRANDED PHARM
19 1TEVA PHARMS
20 2TEVA PHARMS USA
21 3ZYDUS LIFESCIENCES
01 18CAPSULE;ORAL
02 16TABLET;ORAL
01 8DISCN
02 26RX
01 2ACTIGALL
02 1URSO 250
03 1URSO FORTE
04 30URSODIOL
01 31No
02 3Yes
RLD : Yes
TE Code : AB
Brand Name : URSO 250
Dosage Form : TABLET;ORAL
Dosage Strength : 250MG
Approval Date : 1997-12-10
Application Number : 20675
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
RLD : No
TE Code :
Brand Name : URSODIOL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 200MG
Approval Date : 2020-05-08
Application Number : 205789
RX/OTC/DISCN : RX
RLD : No
TE Code :
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
RLD : No
TE Code : AB
Brand Name : URSODIOL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 300MG
Approval Date : 2021-01-22
Application Number : 210344
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : Yes
TE Code : AB
Brand Name : URSO FORTE
Dosage Form : TABLET;ORAL
Dosage Strength : 500MG
Approval Date : 2004-07-21
Application Number : 20675
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
RLD : No
TE Code :
Brand Name : URSODIOL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 400MG
Approval Date : 2020-05-08
Application Number : 205789
RX/OTC/DISCN : RX
RLD : No
TE Code :
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
RLD : No
TE Code : AB
Brand Name : URSODIOL
Dosage Form : TABLET;ORAL
Dosage Strength : 250MG
Approval Date : 2020-08-20
Application Number : 213504
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
RLD : No
TE Code : AB
Brand Name : URSODIOL
Dosage Form : TABLET;ORAL
Dosage Strength : 500MG
Approval Date : 2020-08-20
Application Number : 213504
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : URSODIOL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 300MG
Approval Date : 2000-03-14
Application Number : 75517
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code :
Brand Name : ACTIGALL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 150MG
Approval Date : 1987-12-31
Application Number : 19594
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code : AB
Brand Name : ACTIGALL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 300MG
Approval Date : 1987-12-31
Application Number : 19594
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
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