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 | 10MG | CAPSULE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 07/28/1976 | 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-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/13/2013 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/31/2012 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/23/1997 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1997 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1997 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1991 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 08/23/1990 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 03/15/1990 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 02/02/1989 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1989 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1988 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/20/1986 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/04/1986 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/21/1983 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1983 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1983 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/10/1983 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/10/1983 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/1982 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
DICYCLOMINE HYDROCHLORIDE
CAPSULE;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 040319 | AUROBINDO PHARMA USA |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 216639 | COREPHARMA |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 084285 | LANNETT |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 217531 | PRINSTON INC |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 217054 | TWI PHARMS |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 085082 | WATSON LABS |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 040204 | WEST WARD |