Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075527
Company: CHARTWELL RX
Company: CHARTWELL RX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET;ORAL | Discontinued | None | No | No |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET;ORAL | Discontinued | None | No | No |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | 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 |
---|---|---|---|---|---|---|---|
09/25/2000 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75527ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75527ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/21/2004 | SUPPL-10 | Labeling |
Label is not available on this site. |
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07/25/2002 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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07/25/2002 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/22/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/22/2002 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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01/22/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/22/2002 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |