Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210106
Company: AMPHASTAR PHARMS INC
Company: AMPHASTAR PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISOPROTERENOL HYDROCHLORIDE | ISOPROTERENOL HYDROCHLORIDE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
06/18/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ISOPROTERENOL HYDROCHLORIDE
INJECTABLE;INJECTION; 0.2MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ISOPROTERENOL HYDROCHLORIDE | ISOPROTERENOL HYDROCHLORIDE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210576 | AMNEAL |
ISOPROTERENOL HYDROCHLORIDE | ISOPROTERENOL HYDROCHLORIDE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210106 | AMPHASTAR PHARMS INC |
ISOPROTERENOL HYDROCHLORIDE | ISOPROTERENOL HYDROCHLORIDE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211237 | AMRING PHARMS |
ISOPROTERENOL HYDROCHLORIDE | ISOPROTERENOL HYDROCHLORIDE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212189 | AVET LIFESCIENCES |
ISOPROTERENOL HYDROCHLORIDE | ISOPROTERENOL HYDROCHLORIDE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211703 | HIKMA |
ISOPROTERENOL HYDROCHLORIDE | ISOPROTERENOL HYDROCHLORIDE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210845 | MICRO LABS |
ISOPROTERENOL HYDROCHLORIDE | ISOPROTERENOL HYDROCHLORIDE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206961 | NEXUS |
ISOPROTERENOL HYDROCHLORIDE | ISOPROTERENOL HYDROCHLORIDE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215542 | PENN LIFE |
ISOPROTERENOL HYDROCHLORIDE | ISOPROTERENOL HYDROCHLORIDE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211590 | SOMERSET THERAPS LLC |