Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075269
Company: VALEANT PHARMS NORTH
Company: VALEANT PHARMS NORTH
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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/04/2000 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75269ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75269ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/075269.PDF |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/09/2012 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
12/16/2002 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/15/2002 | SUPPL-5 | 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. |
||
02/14/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
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 |