Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064139
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMOXICILLIN | AMOXICILLIN | 125MG | TABLET, CHEWABLE;ORAL | Discontinued | None | No | No |
| AMOXICILLIN | AMOXICILLIN | 250MG | TABLET, CHEWABLE;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 |
|---|---|---|---|---|---|---|---|
| 01/29/1996 | 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 |
|---|---|---|---|---|---|
| 11/30/2001 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 07/13/2001 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 03/12/2001 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 11/27/2000 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 11/17/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 01/25/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 06/09/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/05/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/13/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 01/13/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |