Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213555
Company: CHARTWELL RX
Company: CHARTWELL RX
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 |
---|---|---|---|---|---|---|---|
08/17/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/17/2020 | SUPPL-1 |
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 | HIBROW HLTHCARE |
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 |