Drugs@FDA: FDA-Approved Drugs
Company: UPSHER SMITH LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 01/07/1987 | 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 |
|---|---|---|---|---|---|
| 01/11/2012 | SUPPL-45 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/28/2014 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/05/2009 | SUPPL-40 | Labeling |
Label is not available on this site. |
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| 02/09/2009 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 11/19/2007 | SUPPL-37 | Labeling |
Label is not available on this site. |
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| 11/17/2004 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 10/31/2003 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 03/26/2003 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 12/16/1997 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 10/18/1996 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 10/18/1996 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1996 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1996 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/09/1995 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/09/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/24/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/24/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/24/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/24/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 02/26/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/26/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/27/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/05/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1987 | 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 |