Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210979
Company: FOSUN PHARMA
Company: FOSUN PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
07/02/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
DICYCLOMINE HYDROCHLORIDE
INJECTABLE;INJECTION; 10MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208353 | AM REGENT |
DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210979 | FOSUN PHARMA |
DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210257 | FRESENIUS KABI USA |
DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206468 | NEXUS |
DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207076 | SLATE RUN PHARMA |
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040465 | HIKMA |