Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087953
Company: WOCKHARDT BIO AG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE PLAIN PROMETHAZINE HYDROCHLORIDE 6.25MG/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
11/15/1982 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
04/04/2006 SUPPL-36 Labeling

Label is not available on this site.

12/21/2005 SUPPL-35 Labeling

Label is not available on this site.

02/17/2000 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/17/2000 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

02/17/2000 SUPPL-30 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/17/2000 SUPPL-29 Labeling

Label is not available on this site.

02/17/2000 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/05/1995 SUPPL-22 Labeling

Label is not available on this site.

08/10/1994 SUPPL-21 Labeling

Label is not available on this site.

02/11/1992 SUPPL-20 Labeling

Label is not available on this site.

01/18/1991 SUPPL-19 Labeling

Label is not available on this site.

01/19/1990 SUPPL-18 Labeling

Label is not available on this site.

03/15/1989 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/16/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/20/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/20/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/20/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/20/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/20/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/20/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/16/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

PROMETHAZINE PLAIN

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 040882 AMNEAL PHARMS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 040026 HI TECH PHARMA
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 040891 NOSTRUM LABS INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 040718 TARO
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 091675 TRIS PHARMA INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 040643 VINTAGE
PROMETHAZINE PLAIN PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 087953 WOCKHARDT BIO AG

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