Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040169
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/5ML | SYRUP;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
03/24/2005 | 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 |
---|---|---|---|---|---|
12/27/2017 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
08/28/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
DICYCLOMINE HYDROCHLORIDE
SYRUP;ORAL; 10MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/5ML | SYRUP;ORAL | Prescription | No | AA | 040169 | ENDO OPERATIONS |
DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/5ML | SYRUP;ORAL | Prescription | No | AA | 212286 | HIKMA |
DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/5ML | SYRUP;ORAL | Prescription | No | AA | 214721 | NOVITIUM PHARMA |