Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210184
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | No | No |
NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | No | No |
NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | 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 |
---|---|---|---|---|---|---|---|
06/29/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
NIFEDIPINE
TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 213361 | AUROBINDO PHARMA |
NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 202987 | NOVAST LABS |
NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 075269 | VALEANT PHARMS NORTH |
NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 210184 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 213361 | AUROBINDO PHARMA |
NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 202987 | NOVAST LABS |
NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 075269 | VALEANT PHARMS NORTH |
NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 210184 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 90MG
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 213361 | AUROBINDO PHARMA |
NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 202987 | NOVAST LABS |
NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 076070 | VALEANT PHARMS NORTH |
NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 210184 | ZYDUS PHARMS |