Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074028
Company: CHARTWELL RX
Company: CHARTWELL RX
| 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 |
|---|---|---|---|---|---|---|---|
| 06/28/1993 | 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 |
|---|---|---|---|---|---|
| 07/10/2025 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/18/2012 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/22/2006 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/13/2002 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/31/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1995 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/25/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/1994 | SUPPL-1 | Labeling |
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 | 074509 | PHARM ASSOC |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Prescription | No | AA | 075060 | PHARMOBEDIENT |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Prescription | No | AA | 214178 | SHREE HARI INTL |