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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088875
Company: WOCKHARDT BIO AG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/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
12/17/1984 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
06/28/2018 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

11/17/2017 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

01/13/2017 SUPPL-37 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/10/2013 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

10/29/2015 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

01/21/2010 SUPPL-32 Labeling

Label is not available on this site.

12/19/2008 SUPPL-31 Labeling

Label is not available on this site.

02/25/2008 SUPPL-30 Labeling

Label is not available on this site.

04/03/2006 SUPPL-29 Labeling

Label is not available on this site.

06/27/2002 SUPPL-26 Labeling

Label is not available on this site.

06/27/2002 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/27/2002 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/18/1991 SUPPL-17 Labeling

Label is not available on this site.

08/23/1990 SUPPL-16 Labeling

Label is not available on this site.

01/31/1990 SUPPL-15 Labeling

Label is not available on this site.

04/05/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/08/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/07/1987 SUPPL-8 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.

03/05/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/05/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

SYRUP;ORAL; 10MG/5ML;6.25MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription Yes AA 088763 ACTAVIS MID ATLANTIC
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 040151 AKORN
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 200894 AMNEAL PHARMS
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 090180 NOSTRUM LABS INC
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 214238 QUAGEN
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 200386 TRIS PHARMA INC
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 088875 WOCKHARDT BIO AG
PROMETHAZINE WITH CODEINE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 040650 PHARM ASSOC
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