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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019797
Company: BRAINTREE

Medication Guide

Products on NDA 019797

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NULYTELY	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION;ORAL	Prescription	AA	Yes	Yes
NULYTELY-FLAVORED	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION;ORAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019797

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/22/1991	ORIG-1	Approval	Type 4 - New Combination	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/14/2021	SUPPL-29	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019797s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019797Orig1s029ltr.pdf
09/23/2013	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019797s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019797Orig1s022ltr.pdf
01/27/2010	SUPPL-18	Labeling		Label is not available on this site.
08/07/2003	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
06/30/2003	SUPPL-13	Manufacturing (CMC)-Formulation	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19797scf013ltr.pdf
02/23/2001	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
10/09/1999	SUPPL-11	Manufacturing (CMC)-Formulation		Label is not available on this site.
01/28/2000	SUPPL-10	Manufacturing (CMC)-Formulation		Label is not available on this site.
12/13/1999	SUPPL-9	Manufacturing (CMC)-Formulation		Label is not available on this site.
03/25/1999	SUPPL-8	Manufacturing (CMC)-Formulation		Label is not available on this site.
12/10/1997	SUPPL-7	Labeling		Label is not available on this site.
12/10/1997	SUPPL-6	Labeling		Label is not available on this site.
06/03/1997	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/04/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
11/02/1995	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/18/1994	SUPPL-2	Manufacturing (CMC)-Formulation		Label is not available on this site.
04/29/1993	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 019797

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/14/2021	SUPPL-29	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019797s029lbl.pdf
05/14/2021	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019797s029lbl.pdf
09/23/2013	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019797s022lbl.pdf

Therapeutic Equivalents for NDA 019797

NULYTELY

FOR SOLUTION;ORAL; 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NULYTELY	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION;ORAL	Prescription	Yes	AA	019797	BRAINTREE
NULYTELY-FLAVORED	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION;ORAL	Prescription	Yes	AA	019797	BRAINTREE
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION;ORAL	Prescription	No	AA	204559	STRIDES PHARMA

NULYTELY-FLAVORED

FOR SOLUTION;ORAL; 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NULYTELY	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION;ORAL	Prescription	Yes	AA	019797	BRAINTREE
NULYTELY-FLAVORED	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION;ORAL	Prescription	Yes	AA	019797	BRAINTREE
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION;ORAL	Prescription	No	AA	204559	STRIDES PHARMA

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