ADALAT از شرکت BAYER PHARMS

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 از شرکت BAYER PHARMS

New Drug Application (NDA): 019478

Company: BAYER PHARMS

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
ADALATNIFEDIPINE10MGCAPSULE;ORALDiscontinued

None

NoNo
ADALATNIFEDIPINE20MGCAPSULE;ORALDiscontinued

None

NoNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
11/27/1985ORIG-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
12/22/1997SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/22/1996SUPPL-11 Labeling

Label is not available on this site.

09/22/1993SUPPL-10 Labeling

Label is not available on this site.

01/23/1992SUPPL-9 Labeling

Label is not available on this site.

09/13/1991SUPPL-8 Labeling

Label is not available on this site.

09/13/1991SUPPL-7 Labeling

Label is not available on this site.

11/21/1989SUPPL-6 Labeling

Label is not available on this site.

08/10/1989SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1988SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/21/1988SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/07/1986SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/17/1986SUPPL-1 Labeling

Label is not available on this site.

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