Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040204
Company: WEST WARD
Company: WEST WARD
| 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 |
|---|---|---|---|---|---|---|---|
| 02/28/1997 | 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 |
|---|---|---|---|---|---|
| 05/11/2012 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/22/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/01/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/1997 | SUPPL-1 | Labeling |
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 | 218018 | ANNORA PHARMA |
| 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 | 219242 | RISING |
| 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 |