Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075517
Company: EPIC PHARMA
Company: EPIC PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
URSODIOL | URSODIOL | 300MG | CAPSULE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/14/2000 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75517ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75517_Ursodiol.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/30/2024 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
04/06/2015 | SUPPL-11 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
08/30/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
04/11/2005 | SUPPL-4 | Labeling |
Label is not available on this site. |
URSODIOL
CAPSULE;ORAL; 300MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ACTIGALL | URSODIOL | 300MG | CAPSULE;ORAL | Prescription | Yes | AB | 019594 | TEVA BRANDED PHARM |
URSODIOL | URSODIOL | 300MG | CAPSULE;ORAL | Prescription | No | AB | 210707 | ABHAI LLC |
URSODIOL | URSODIOL | 300MG | CAPSULE;ORAL | Prescription | No | AB | 211301 | AMNEAL PHARMS CO |
URSODIOL | URSODIOL | 300MG | CAPSULE;ORAL | Prescription | No | AB | 214849 | AUROBINDO PHARMA LTD |
URSODIOL | URSODIOL | 300MG | CAPSULE;ORAL | Prescription | No | AB | 213555 | CHARTWELL RX |
URSODIOL | URSODIOL | 300MG | CAPSULE;ORAL | Prescription | No | AB | 075517 | EPIC PHARMA |
URSODIOL | URSODIOL | 300MG | CAPSULE;ORAL | Prescription | No | AB | 212452 | EYWA PHARMA |
URSODIOL | URSODIOL | 300MG | CAPSULE;ORAL | Prescription | No | AB | 079082 | LANNETT CO INC |
URSODIOL | URSODIOL | 300MG | CAPSULE;ORAL | Prescription | No | AB | 213200 | RISING |
URSODIOL | URSODIOL | 300MG | CAPSULE;ORAL | Prescription | No | AB | 214329 | RK PHARMA |
URSODIOL | URSODIOL | 300MG | CAPSULE;ORAL | Prescription | No | AB | 210344 | STRIDES PHARMA |
URSODIOL | URSODIOL | 300MG | CAPSULE;ORAL | Prescription | No | AB | 214295 | ZYDUS LIFESCIENCES |