Drugs@FDA: FDA-Approved Drugs
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/17/1976 | 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 |
|---|---|---|---|---|---|
| 11/27/2013 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/13/2013 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/31/2012 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/25/1998 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 07/16/1997 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1997 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/1996 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/19/1996 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/1996 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/26/1995 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1994 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1991 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 08/23/1990 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 03/15/1990 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 03/31/1989 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1989 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1988 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1986 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1986 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1982 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1982 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/1982 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1979 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
DICYCLOMINE HYDROCHLORIDE
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 040317 | AUROBINDO PHARMA USA |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 217916 | BIONPHARMA |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 216760 | COREPHARMA |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 040161 | HIKMA PHARMS |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 040230 | LANNETT |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 216736 | RUBICON |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 216782 | TWI PHARMS |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 085223 | WATSON LABS |