Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203978
Company: INFORLIFE
Company: INFORLIFE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | AP | No | No |
NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE;INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
04/17/2024 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203978Orig1s000ltr.pdf |
NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE
INJECTABLE;INTRAVENOUS; 40MG/200ML (0.2MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER | NICARDIPINE HYDROCHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 019734 | CHIESI |
NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203978 | INFORLIFE |
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 215592 | CIPLA |
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 022276 | HIKMA INTL PHARMS |
NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE
INJECTABLE;INTRAVENOUS; 20MG/200ML (0.1MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER | NICARDIPINE HYDROCHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 019734 | CHIESI |
NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203978 | INFORLIFE |
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 215592 | CIPLA |
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 022276 | HIKMA INTL PHARMS |