ADALAT CC از شرکت ALVOGEN

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

ADALAT CC از شرکت ALVOGEN

New Drug Application (NDA): 020198

Company: ALVOGEN

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
ADALAT CCNIFEDIPINE30MGTABLET, EXTENDED RELEASE;ORALDiscontinued

None

YesNo
ADALAT CCNIFEDIPINE60MGTABLET, EXTENDED RELEASE;ORALDiscontinued

None

YesNo
ADALAT CCNIFEDIPINE90MGTABLET, EXTENDED RELEASE;ORALDiscontinued

None

YesNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
04/21/1993ORIG-1 Approval

Type 5 – New Formulation or New Manufacturer

STANDARD

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
05/17/2016SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

02/28/2011SUPPL-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

03/03/2010SUPPL-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

04/01/2005SUPPL-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

04/13/1999SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

07/07/1994SUPPL-3 Labeling

Label is not available on this site.

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

Label is not available on this site.

07/23/1993SUPPL-1 Labeling

Label is not available on this site.

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
02/28/2011SUPPL-23

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020198s023lbl.pdf
03/03/2010SUPPL-22

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020198s022lbl.pdf
04/01/2005SUPPL-17

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20198s017lbl.pdf
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