Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022525
Company: ABBVIE
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NAMENDA XR | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
NAMENDA XR | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
NAMENDA XR | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
NAMENDA XR | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
06/21/2010 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022525s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022525s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022525s000_namenda_xr_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022525Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/22/2019 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022525s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022525Orig1s015ltr.pdf | |
01/06/2017 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/18/2015 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/17/2016 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/09/2014 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/26/2014 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022525s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022525Orig1s006ltr.pdf | |
07/03/2014 | SUPPL-5 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022525s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022525Orig1s005ltr.pdf | |
11/14/2013 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/20/2013 | 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 |
---|---|---|---|---|---|
11/22/2019 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022525s015lbl.pdf | |
09/26/2014 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022525s006lbl.pdf | |
07/03/2014 | SUPPL-5 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022525s005lbl.pdf | |
06/21/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022525s000lbl.pdf |
NAMENDA XR
CAPSULE, EXTENDED RELEASE;ORAL; 14MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205825 | AMNEAL PHARMS |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206135 | APOTEX |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214651 | AUROBINDO PHARMA LTD |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206028 | LUPIN LTD |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213985 | XIAMEN LP PHARM CO |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211100 | YICHANG HUMANWELL |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203293 | ZYDUS PHARMS |
NAMENDA XR | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022525 | ABBVIE |
CAPSULE, EXTENDED RELEASE;ORAL; 21MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205825 | AMNEAL PHARMS |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206135 | APOTEX |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214651 | AUROBINDO PHARMA LTD |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206028 | LUPIN LTD |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213985 | XIAMEN LP PHARM CO |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211100 | YICHANG HUMANWELL |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203293 | ZYDUS PHARMS |
NAMENDA XR | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022525 | ABBVIE |
CAPSULE, EXTENDED RELEASE;ORAL; 28MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205825 | AMNEAL PHARMS |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206135 | APOTEX |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214651 | AUROBINDO PHARMA LTD |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206028 | LUPIN LTD |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213985 | XIAMEN LP PHARM CO |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211100 | YICHANG HUMANWELL |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203293 | ZYDUS PHARMS |
NAMENDA XR | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022525 | ABBVIE |