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ACEPHEN از شرکت COSETTE

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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
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ACEPHEN از شرکت COSETTE

Abbreviated New Drug Application (ANDA): 072237

Company: COSETTE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACEPHEN ACETAMINOPHEN 650MG SUPPOSITORY;RECTAL Over-the-counter

None

No 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
03/27/1992 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/10/2015 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

11/10/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

09/24/2013 SUPPL-9 Labeling-Container/Carton Labels

Label is not available on this site.

08/19/2010 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

08/19/2010 SUPPL-7 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

04/29/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/04/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/10/1992 SUPPL-1 Labeling

Label is not available on this site.

ACEPHEN

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SUPPOSITORY;RECTAL; 650MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ACEPHEN ACETAMINOPHEN 650MG SUPPOSITORY;RECTAL Over-the-counter No 072237 COSETTE
ACETAMINOPHEN ACETAMINOPHEN 650MG SUPPOSITORY;RECTAL Over-the-counter No 070608 PERRIGO NEW YORK
ACETAMINOPHEN ACETAMINOPHEN 650MG SUPPOSITORY;RECTAL Over-the-counter Yes 018337 TARO PHARM INDS LTD
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