Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088251
Company: WOCKHARDT BIO AG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXCHLORPHENIRAMINE MALEATE DEXCHLORPHENIRAMINE MALEATE 2MG/5ML SYRUP;ORAL Prescription AA No 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
03/23/1984 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
04/20/2004 SUPPL-15 Labeling

Label is not available on this site.

04/12/1994 SUPPL-14 Labeling

Label is not available on this site.

08/04/1993 SUPPL-13 Labeling

Label is not available on this site.

09/18/1991 SUPPL-12 Labeling

Label is not available on this site.

04/10/1991 SUPPL-11 Labeling

Label is not available on this site.

10/24/1989 SUPPL-10 Labeling

Label is not available on this site.

04/05/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/22/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/07/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/07/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/22/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/08/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

DEXCHLORPHENIRAMINE MALEATE

SYRUP;ORAL; 2MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXCHLORPHENIRAMINE MALEATE DEXCHLORPHENIRAMINE MALEATE 2MG/5ML SYRUP;ORAL Prescription No AA 088251 WOCKHARDT BIO AG
POLMON DEXCHLORPHENIRAMINE MALEATE 2MG/5ML SYRUP;ORAL Prescription No AA 202520 CAPELLON PHARMS LLC

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