Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084441
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BETHANECHOL CHLORIDE | BETHANECHOL CHLORIDE | 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 |
|---|---|---|---|---|---|---|---|
| 01/14/1975 | 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 |
|---|---|---|---|---|---|
| 04/18/1996 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 03/22/1991 | SUPPL-45 | Labeling |
Label is not available on this site. |
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| 01/28/1991 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1991 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/16/1988 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/1988 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/16/1988 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/11/1987 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/19/1985 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/08/1984 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1983 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/12/1982 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |