Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203293
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | 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 |
---|---|---|---|---|---|---|---|
08/03/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203293Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/15/2020 | SUPPL-1 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
MEMANTINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL; 7MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205825 | AMNEAL PHARMS |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206135 | APOTEX |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214651 | AUROBINDO PHARMA LTD |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206028 | LUPIN LTD |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213985 | XIAMEN LP PHARM CO |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211100 | YICHANG HUMANWELL |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203293 | ZYDUS PHARMS |
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 |
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 |
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 |