Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088864
Company: WOCKHARDT BIO AG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE W/ DEXTROMETHORPHAN DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription AA 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
01/04/1985 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
06/07/2006 SUPPL-27 Labeling

Label is not available on this site.

07/09/1997 SUPPL-23 Labeling

Label is not available on this site.

07/09/1997 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/09/1997 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/09/1997 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/09/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/09/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/18/1991 SUPPL-16 Labeling

Label is not available on this site.

08/24/1990 SUPPL-15 Labeling

Label is not available on this site.

06/19/1989 SUPPL-14 Labeling

Label is not available on this site.

04/05/1989 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/16/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/07/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/07/1987 SUPPL-6 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.

04/07/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/26/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/06/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

PROMETHAZINE W/ DEXTROMETHORPHAN

SYRUP;ORAL; 15MG/5ML;6.25MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROMETHAZINE DM DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 040649 VINTAGE
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 040027 HI TECH PHARMA
PROMETHAZINE W/ DEXTROMETHORPHAN DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 088864 WOCKHARDT BIO AG

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