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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211020
Company: GRAVITI PHARMS

Products on ANDA 211020

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB3	No	No
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB3	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211020

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/28/2019	ORIG-1	Approval		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
06/14/2022	SUPPL-12	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/15/2022	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
06/14/2022	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
06/30/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211020

BUPROPION HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 150MG
TE Code = AB3

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	210497	ACCORD HLTHCARE
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	077715	ACTAVIS LABS FL INC
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	207224	ANBISON LAB
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	215568	GRANULES
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	211020	GRAVITI PHARMS
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	090693	LUPIN LTD
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	207479	SCIEGEN PHARMS INC
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	208652	SINOTHERAPEUTICS INC
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	200216	SUN PHARM
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	210081	TWI PHARMS
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	077285	WATSON LABS INC
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	202189	WOCKHARDT LTD
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	210015	YICHANG HUMANWELL
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	211200	ZHEJIANG JUTAI PHARM
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	201567	ZYDUS PHARMS
WELLBUTRIN XL	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB3	021515	BAUSCH

TABLET, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB3

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	210497	ACCORD HLTHCARE
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	207224	ANBISON LAB
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	215568	GRANULES
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	211020	GRAVITI PHARMS
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	090693	LUPIN LTD
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	207479	SCIEGEN PHARMS INC
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	208652	SINOTHERAPEUTICS INC
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	203650	SUN PHARM
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	210081	TWI PHARMS
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	077285	WATSON LABS INC
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	202189	WOCKHARDT LTD
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	210015	YICHANG HUMANWELL
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	211200	ZHEJIANG JUTAI PHARM
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	201567	ZYDUS PHARMS
WELLBUTRIN XL	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB3	021515	BAUSCH

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