Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074509
Company: PHARM ASSOC
Company: PHARM ASSOC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 07/17/1995 | 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 |
|---|---|---|---|---|---|
| 06/05/2012 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/26/2011 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/07/2009 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/29/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/19/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/03/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 09/14/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/01/2006 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 09/18/2002 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/20/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/20/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
AMANTADINE HYDROCHLORIDE
SYRUP;ORAL; 50MG/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Prescription | No | AA | 074170 | AUROBINDO PHARMA USA |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Prescription | No | AA | 074028 | CHARTWELL RX |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Prescription | No | AA | 075819 | CMP PHARMA INC |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Prescription | No | AA | 214178 | ELYSIUM |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Prescription | No | AA | 074509 | PHARM ASSOC |