Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070183
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLDOPA AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METHYLDOPA | 25MG;250MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/15/1986 | 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 |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/06/2020 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/25/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/25/1998 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/02/1996 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 08/19/1996 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/24/1994 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/02/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 04/30/1993 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 01/31/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 09/15/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 02/17/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/17/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/29/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/04/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/04/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/04/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/04/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/11/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |