Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075289
Company: VALEANT PHARMS NORTH
Company: VALEANT PHARMS NORTH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB2 | No | No |
NIFEDIPINE | NIFEDIPINE | 30MG | 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 |
---|---|---|---|---|---|---|---|
09/27/2000 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/075289.PDF |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/08/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
12/16/2002 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/04/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/28/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/15/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/06/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75289S1Ltr.pdf |
NIFEDIPINE
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; 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 |