Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085882
Company: CHARTWELL RX
Company: CHARTWELL RX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DUVOID | BETHANECHOL CHLORIDE | 50MG | TABLET;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
03/22/1978 | 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 |
---|---|---|---|---|---|
01/28/2005 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
11/17/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/11/1990 | SUPPL-14 | Labeling |
Label is not available on this site. |
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03/12/1985 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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05/09/1983 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
DUVOID
TABLET;ORAL; 50MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BETHANECHOL CHLORIDE | BETHANECHOL CHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AA | 040855 | AMNEAL PHARM |
BETHANECHOL CHLORIDE | BETHANECHOL CHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AA | 040728 | CHARTWELL RX |
BETHANECHOL CHLORIDE | BETHANECHOL CHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AA | 040636 | UPSHER SMITH LABS |
DUVOID | BETHANECHOL CHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AA | 085882 | CHARTWELL RX |