Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020198
Company: ALVOGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADALAT CC NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription AB1 Yes No
ADALAT CC NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription AB1 Yes Yes
ADALAT CC NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription AB1 Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/21/1993 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/17/2016 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/09/2015 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/28/2011 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020198s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020198s023ltr.pdf
03/03/2010 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020198s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020198s022ltr.pdf
04/01/2005 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20198s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20198s017ltr.pdf
04/13/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/18/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/23/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/14/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/24/1996 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/14/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/29/1996 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/28/1994 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/07/1994 SUPPL-3 Labeling

Label is not available on this site.

12/06/1993 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/1993 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/28/2011 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020198s023lbl.pdf
03/03/2010 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020198s022lbl.pdf
04/01/2005 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20198s017lbl.pdf

ADALAT CC

TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADALAT CC NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB1 020198 ALVOGEN
AFEDITAB CR NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 075128 WATSON LABS TEVA
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 201071 MYLAN
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 202987 NOVAST LABS LTD
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 077899 PAR PHARM
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 075269 VALEANT PHARMS NORTH

TABLET, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADALAT CC NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB1 020198 ALVOGEN
AFEDITAB CR NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 075659 WATSON LABS
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 201071 MYLAN
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 202987 NOVAST LABS LTD
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 077899 PAR PHARM
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 075269 VALEANT PHARMS NORTH

TABLET, EXTENDED RELEASE;ORAL; 90MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADALAT CC NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB1 020198 ALVOGEN
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 201071 MYLAN
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 202987 NOVAST LABS LTD
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 077899 PAR PHARM
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 076070 VALEANT PHARMS NORTH

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