Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203126
Company: TWI PHARMS
Company: TWI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB2 | No | No |
NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB2 | No | No |
NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB2 | 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 |
---|---|---|---|---|---|---|---|
04/03/2014 | 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 |
---|---|---|---|---|---|
11/24/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
11/24/2015 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
NIFEDIPINE
TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB2
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 | AB2 | 216896 | ALEMBIC |
NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 216067 | ALKEM LABS LTD |
NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210614 | NOVAST LABS |
NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 077127 | OSMOTICA PHARM US |
NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210838 | SPIL |
NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 203126 | TWI PHARMS |
NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 075289 | VALEANT PHARMS NORTH |
NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210012 | ZYDUS PHARMS |
PROCARDIA XL | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 019684 | PFIZER |
TABLET, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB2
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 | AB2 | 216896 | ALEMBIC |
NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 216067 | ALKEM LABS LTD |
NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210614 | NOVAST LABS |
NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 077127 | OSMOTICA PHARM US |
NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210838 | SPIL |
NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 203126 | TWI PHARMS |
NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 075289 | VALEANT PHARMS NORTH |
NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210012 | ZYDUS PHARMS |
PROCARDIA XL | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 019684 | PFIZER |
TABLET, EXTENDED RELEASE;ORAL; 90MG
TE Code = AB2
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 | AB2 | 216896 | ALEMBIC |
NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 216067 | ALKEM LABS LTD |
NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 212016 | ELITE PHARM SOLUTION |
NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210614 | NOVAST LABS |
NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 077127 | OSMOTICA PHARM US |
NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210838 | SPIL |
NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 203126 | TWI PHARMS |
NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210012 | ZYDUS PHARMS |
PROCARDIA XL | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 019684 | PFIZER |