Drugs@FDA: FDA-Approved Drugs
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIORESAL | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | AP | Yes | Yes |
LIORESAL | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | AP | Yes | Yes |
LIORESAL | BACLOFEN | 0.05MG/ML | INJECTABLE;INTRATHECAL | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
06/17/1992 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
12/13/2021 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020075Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020075Orig1s038ltr.pdf | |
01/16/2019 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020075s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020075Orig1s037ltr.pdf | |
12/22/2016 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/30/2016 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020075s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020075Orig1s032ltr.pdf | |
11/19/2014 | SUPPL-31 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020075Orig1s031ltr.pdf |
06/05/2014 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/07/2016 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/19/2013 | SUPPL-28 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020075s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020075Orig1s028ltr.pdf | |
09/05/2013 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/06/2013 | SUPPL-26 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020075s026lbl.pdf | |
01/10/2013 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/13/2011 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020075s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020075s024ltr.pdf | |
03/25/2011 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020075s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020075s021ltr.pdf | |
05/08/2003 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20075scp020ltr.pdf |
01/17/2003 | SUPPL-19 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20075scm019ltr.pdf |
12/10/2002 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/21/2002 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20075scp017ltr.pdf |
03/06/2002 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20075s14s16ltr.pdf |
05/03/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/06/2002 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20075s14s16ltr.pdf |
05/05/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/21/1998 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
08/21/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/23/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/03/2000 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/07/1996 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
06/14/1996 | SUPPL-4 | Efficacy-New Indication |
Label is not available on this site. |
||
05/20/1994 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/13/2021 | SUPPL-38 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020075Orig1s038lbl.pdf | |
01/16/2019 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020075s037lbl.pdf | |
09/30/2016 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020075s032lbl.pdf | |
11/19/2013 | SUPPL-28 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020075s028lbl.pdf | |
03/06/2013 | SUPPL-26 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020075s026lbl.pdf |
11/13/2011 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020075s024lbl.pdf | |
03/25/2011 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020075s021lbl.pdf |
LIORESAL
INJECTABLE;INTRATHECAL; 0.5MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BACLOFEN | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 091193 | AMNEAL |
BACLOFEN | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 210048 | MAIA PHARMS INC |
BACLOFEN | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 209592 | MYLAN LABS LTD |
BACLOFEN | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 217324 | RUBICON |
GABLOFEN | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | Yes | AP | 022462 | PIRAMAL CRITICAL |
LIORESAL | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | Yes | AP | 020075 | AMNEAL |
INJECTABLE;INTRATHECAL; 2MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BACLOFEN | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 091193 | AMNEAL |
BACLOFEN | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 210048 | MAIA PHARMS INC |
BACLOFEN | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 209592 | MYLAN LABS LTD |
BACLOFEN | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 217324 | RUBICON |
GABLOFEN | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | Yes | AP | 022462 | PIRAMAL CRITICAL |
LIORESAL | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | Yes | AP | 020075 | AMNEAL |
INJECTABLE;INTRATHECAL; 0.05MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BACLOFEN | BACLOFEN | 0.05MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 091193 | AMNEAL |
BACLOFEN | BACLOFEN | 0.05MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 210777 | MAIA PHARMS INC |
GABLOFEN | BACLOFEN | 0.05MG/ML | INJECTABLE;INTRATHECAL | Prescription | Yes | AP | 022462 | PIRAMAL CRITICAL |
LIORESAL | BACLOFEN | 0.05MG/ML | INJECTABLE;INTRATHECAL | Prescription | Yes | AP | 020075 | AMNEAL |