Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022462
Company: PIRAMAL CRITICAL
Company: PIRAMAL CRITICAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GABLOFEN | BACLOFEN | 0.05MG/ML | INJECTABLE;INTRATHECAL | Prescription | AP | Yes | Yes |
GABLOFEN | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | AP | Yes | Yes |
GABLOFEN | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | AP | Yes | Yes |
GABLOFEN | BACLOFEN | 1MG/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 |
---|---|---|---|---|---|---|---|
11/19/2010 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022462s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022462s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022462Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022462Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/31/2022 | SUPPL-15 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022462Orig1s015Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022462Orig1s015ltr.pdf | |
04/19/2021 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022462s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022462Orig1s013ltr.pdf | |
12/19/2019 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022462s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022462Orig1s011ltr.pdf | |
02/11/2015 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022462s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022462Orig1s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022462Orig1s008.pdf | |
01/17/2013 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/22/2012 | SUPPL-2 | 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 |
---|---|---|---|---|---|
05/31/2022 | SUPPL-15 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022462Orig1s015Lbl.pdf | |
04/19/2021 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022462s013lbl.pdf | |
12/19/2019 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022462s011lbl.pdf | |
02/11/2015 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022462s008lbl.pdf | |
11/19/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022462s000lbl.pdf |
GABLOFEN
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 |
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; 1MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BACLOFEN | BACLOFEN | 1MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 210315 | MAIA PHARMS INC |
BACLOFEN | BACLOFEN | 1MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 209594 | MYLAN LABS LTD |
BACLOFEN | BACLOFEN | 1MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 217324 | RUBICON |
GABLOFEN | BACLOFEN | 1MG/ML | INJECTABLE;INTRATHECAL | Prescription | Yes | AP | 022462 | PIRAMAL CRITICAL |