Drugs@FDA: FDA-Approved Drugs

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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 Discontinued None Yes No
ADALAT CC NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
ADALAT CC NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes 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
04/21/1993 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

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