Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017364
Company: MEDPOINTE PHARM HLC
Company: MEDPOINTE PHARM HLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AQUATENSEN | METHYCLOTHIAZIDE | 5MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/07/1977 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/12/1992 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/20/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 12/03/1990 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/22/1988 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 01/24/1985 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/28/1983 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 09/29/1987 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 10/15/1981 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/26/1979 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/16/1980 | SUPPL-1 | Labeling |
Label is not available on this site. |