Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090534
Company: AM REGENT
Company: AM REGENT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/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 |
---|---|---|---|---|---|---|---|
11/17/2009 | 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 |
---|---|---|---|---|---|
06/02/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
06/02/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
NICARDIPINE HYDROCHLORIDE
INJECTABLE;INJECTION; 25MG/10ML (2.5MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090534 | AM REGENT |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 217548 | CHENGDU SHUODE |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 211121 | EUGIA PHARMA |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 022276 | HIKMA INTL PHARMS |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 216420 | MICRO LABS |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090664 | RK PHARMA |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090671 | WOCKHARDT |