Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019594
Company: TEVA BRANDED PHARM
Company: TEVA BRANDED PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACTIGALL | URSODIOL | 150MG | CAPSULE;ORAL | Discontinued | None | No | No |
| ACTIGALL | URSODIOL | 300MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/31/1987 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/19/2023 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019594s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019594Orig1s037ltr.pdf | |
| 06/27/2016 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/2015 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/2002 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019594s21lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19594slr021ltr.pdf | |
| 04/22/1999 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/19/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/05/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/1995 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1996 | SUPPL-16 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/15/2002 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/24/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/05/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/04/1991 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/19/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/02/1989 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/19/1989 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/30/1988 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/26/1988 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/08/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/08/1988 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/14/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/19/2023 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019594s037lbl.pdf | |
| 08/14/2002 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019594s21lbl.pdf |
ACTIGALL
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 |