Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072655
Company: G AND W LABS INC
Company: G AND W LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 10/30/1990 | 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 |
|---|---|---|---|---|---|
| 07/29/2011 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/16/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/08/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/13/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 08/10/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/10/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/10/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/02/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/30/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 09/04/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |