Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075060
Company: PHARMOBEDIENT
Company: PHARMOBEDIENT
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 12/24/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75060ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/10/2025 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/24/2024 | SUPPL-12 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/31/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/14/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 01/12/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/15/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
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 |