Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 02/18/1987 | 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 |
|---|---|---|---|---|---|
| 09/11/2019 | SUPPL-40 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/11/2019 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/25/2009 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 11/20/2008 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 04/01/2008 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 05/11/2004 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 11/08/2002 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/08/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/2002 | SUPPL-17 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/07/2002 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/07/2002 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/17/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/1996 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 01/25/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/11/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/27/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/30/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
AMANTADINE HYDROCHLORIDE
CAPSULE;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 | CAPSULE;ORAL | Prescription | No | AB | 208966 | ALEMBIC |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 078720 | BIONPHARMA |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 209171 | HERITAGE PHARMA |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 214580 | HUMANWELL PURACAP |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 210129 | RISING |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 212044 | RUBICON |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 071293 | SANDOZ |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 209047 | STRIDES PHARMA |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 211354 | STRIDES PHARMA |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 070589 | UPSHER SMITH LABS |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 208278 | ZYDUS PHARMS |