Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040161
Company: HIKMA PHARMS
Company: HIKMA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 10/01/1996 | 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 |
|---|---|---|---|---|---|
| 03/05/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/11/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/17/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/06/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/01/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/10/1997 | SUPPL-1 | 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 |