Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217555
Company: BIONPHARMA
Company: BIONPHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG | CAPSULE;ORAL | Prescription | AB | No | No |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
05/03/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
NICARDIPINE HYDROCHLORIDE
CAPSULE;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 074670 | ANI PHARMS |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 217555 | BIONPHARMA |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 074928 | EPIC PHARMA LLC |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 216357 | GLENMARK PHARMS LTD |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 215377 | SENORES PHARMS |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 218202 | SKG PHARMA |
CAPSULE;ORAL; 30MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 074670 | ANI PHARMS |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 217555 | BIONPHARMA |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 074928 | EPIC PHARMA LLC |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 216357 | GLENMARK PHARMS LTD |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 215377 | SENORES PHARMS |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 218202 | SKG PHARMA |