AMBENYL از شرکت FOREST LABS

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

AMBENYL از شرکت FOREST LABS

New Drug Application (NDA): 009319

Company: FOREST LABS

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
AMBENYLBROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE12.5MG/5ML;10MG/5MLSYRUP;ORALDiscontinued

None

NoNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
04/28/1954ORIG-1 Approval

Type 4 – New Combination

STANDARD

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
04/14/1993SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/22/1989SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/1993SUPPL-24 Labeling

Label is not available on this site.

08/26/1988SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/27/1986SUPPL-21 Labeling

Label is not available on this site.

01/10/1984SUPPL-18 Efficacy

Label is not available on this site.

01/10/1984SUPPL-17 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/07/2007SUPPL-16 Labeling

Label is not available on this site.

12/07/2007SUPPL-14 Labeling

Label is not available on this site.

12/07/2007SUPPL-13 Labeling

Label is not available on this site.

12/07/2007SUPPL-12 Labeling

Label is not available on this site.

12/07/2007SUPPL-11 Labeling

Label is not available on this site.

12/07/2007SUPPL-9 Labeling

Label is not available on this site.

12/07/2007SUPPL-8 Labeling

Label is not available on this site.

12/07/2007SUPPL-6 Labeling

Label is not available on this site.

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