Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018191
Company: SCHERING PLOUGH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AFRINOL PSEUDOEPHEDRINE SULFATE 120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/30/1980 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
07/11/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/2000 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/2000 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1998 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/17/1998 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/15/1996 SUPPL-8 Labeling

Label is not available on this site.

01/24/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/02/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/08/1986 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1984 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/21/1983 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/10/1981 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

AFRINOL

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

TABLET, EXTENDED RELEASE;ORAL; 120MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
AFRINOL PSEUDOEPHEDRINE SULFATE 120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 018191 SCHERING PLOUGH

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