Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074100
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIMETIDINE | CIMETIDINE | 200MG | TABLET;ORAL | Discontinued | None | No | No |
| CIMETIDINE | CIMETIDINE | 300MG | TABLET;ORAL | Discontinued | None | No | No |
| CIMETIDINE | CIMETIDINE | 400MG | TABLET;ORAL | Discontinued | None | No | No |
| CIMETIDINE | CIMETIDINE | 800MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 01/31/1995 | 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 |
|---|---|---|---|---|---|
| 04/19/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/09/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/13/2001 | SUPPL-15 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 12/13/2001 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 12/13/2001 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/13/2001 | SUPPL-12 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 04/04/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/05/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/28/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/29/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/14/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/04/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 05/04/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/24/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/19/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/19/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |