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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020198
Company: NORWICH

Products on NDA 020198

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADALAT CC	NIFEDIPINE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ADALAT CC	NIFEDIPINE	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ADALAT CC	NIFEDIPINE	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020198

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.

Labels for NDA 020198

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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