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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090180
Company: NOSTRUM LABS INC

Products on ANDA 090180

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
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE	PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE	10MG; 5ML	SYRUP; ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090180

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/2010	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090180s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
06/28/2018	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
08/29/2017	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/13/2017	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/10/2013	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090180

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	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

PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE

There are no Therapeutic Equivalents.

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