Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206332
Company: NEXUS
Company: NEXUS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE | 500MG/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 |
---|---|---|---|---|---|---|---|
10/13/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
PROCAINAMIDE HYDROCHLORIDE
INJECTABLE;INJECTION; 100MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 089069 | HOSPIRA |
PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 088636 | INTL MEDICATION |
PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206332 | NEXUS |
INJECTABLE;INJECTION; 500MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE | 500MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 089070 | HOSPIRA |
PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE | 500MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206332 | NEXUS |