Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206032
Company: MYLAN
Company: MYLAN
| 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 | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/28/2016 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206032Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/15/2020 | SUPPL-4 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 03/15/2020 | SUPPL-1 | 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 | 205784 | ANCHEN PHARMS |
| MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205365 | ANI PHARMS INC |
| 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 | 206028 | LUPIN LTD |
| MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206032 | MYLAN |
| MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203293 | ZYDUS PHARMS |
| NAMENDA XR | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022525 | FOREST LABS LLC |
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 | 205784 | ANCHEN PHARMS |
| MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205365 | ANI PHARMS INC |
| 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 | 206028 | LUPIN LTD |
| MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206032 | MYLAN |
| 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 | FOREST LABS LLC |
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 | 205784 | ANCHEN PHARMS |
| MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205365 | ANI PHARMS INC |
| 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 | 206028 | LUPIN LTD |
| MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206032 | MYLAN |
| 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 | FOREST LABS LLC |
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 | 205784 | ANCHEN PHARMS |
| MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205365 | ANI PHARMS INC |
| 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 | 206028 | LUPIN LTD |
| MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206032 | MYLAN |
| 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 | FOREST LABS LLC |
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