Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076186
Company: UPSHER SMITH LABS
Company: UPSHER SMITH LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | TABLET;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 |
---|---|---|---|---|---|---|---|
12/16/2002 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/13/2017 | SUPPL-22 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
01/18/2012 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
06/04/2009 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
02/09/2009 | SUPPL-10 | Labeling |
Label is not available on this site. |
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11/19/2007 | SUPPL-9 | Labeling |
Label is not available on this site. |
AMANTADINE HYDROCHLORIDE
TABLET;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 214284 | ALEMBIC |
AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 210215 | ATHEM |
AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 209035 | STRIDES PHARMA |
AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 076186 | UPSHER SMITH LABS |
AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 208096 | WATSON LABS INC |