Drugs@FDA: FDA-Approved Drugs
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NAMENDA | MEMANTINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | AB | Yes | No |
NAMENDA | MEMANTINE HYDROCHLORIDE | 10MG | TABLET;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 |
---|---|---|---|---|---|---|---|
10/16/2003 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021487lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21487ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-487_Namenda.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/02/2018 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021487s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021487Orig1s025ltr.pdf | |
05/18/2016 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/07/2016 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/29/2015 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/14/2013 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/11/2013 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/24/2013 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487Orig1s010,s012,s014,021627Orig1s008ltr.pdf | |
10/24/2013 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487Orig1s010,s012,s014,021627Orig1s008ltr.pdf | |
10/24/2013 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487s010ltr.pdf021487Orig1s010,s012,s014,021627Orig1s008ltr.pdf | |
10/04/2006 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s008,021627s001LTR.pdf |
04/19/2006 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s007, 021627s002LTR.pdf |
05/17/2005 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021487s006ltr.pdf |
05/02/2005 | SUPPL-4 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021487s004ltr.pdf |
09/22/2004 | SUPPL-2 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21487s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/02/2018 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021487s025lbl.pdf | |
10/24/2013 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf | |
10/24/2013 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf | |
10/24/2013 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf | |
10/16/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021487lbl.pdf |
NAMENDA
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 206528 | AJANTA PHARMA LTD |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 200891 | ALEMBIC |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090041 | AMNEAL PHARMS |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 203175 | AUROBINDO PHARMA LTD |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090048 | DR REDDYS LABS LTD |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 204389 | HETERO LABS LTD V |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090051 | LUPIN LTD |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 202840 | MACLEODS PHARMS LTD |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 210587 | POLYGEN PHARMS |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 206855 | PURACAP PHARM LLC |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 209527 | RENATA |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 202350 | STRIDES PHARMA |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090058 | SUN PHARM |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 200022 | UNICHEM |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090043 | UPSHER SMITH LABS |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090961 | ZYDUS LIFESCIENCES |
NAMENDA | MEMANTINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 021487 | ABBVIE |
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 206528 | AJANTA PHARMA LTD |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 200891 | ALEMBIC |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 090041 | AMNEAL PHARMS |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 203175 | AUROBINDO PHARMA LTD |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 090048 | DR REDDYS LABS LTD |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 204389 | HETERO LABS LTD V |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 090051 | LUPIN LTD |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 202840 | MACLEODS PHARMS LTD |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 210587 | POLYGEN PHARMS |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 206855 | PURACAP PHARM LLC |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 209527 | RENATA |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 202350 | STRIDES PHARMA |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 090058 | SUN PHARM |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 200022 | UNICHEM |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 090043 | UPSHER SMITH LABS |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 090961 | ZYDUS LIFESCIENCES |
NAMENDA | MEMANTINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 021487 | ABBVIE |