Application 207479

Type: ANDA
Sponsor: SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	150MG	No	No
002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207479-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2017-04-12
A207479-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2017-04-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207479-001	AB3
A207479-002	AB3

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2017-04-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2017-04-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A207479-001	AB3	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207479-002	AB3	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	4cc3327b-92c5-4667-ae16-3e95eafcf4d8	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	30c370c2-f2b7-4335-ba55-e8c8f4059092	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	8499470a-8d01-4348-b67b-8f49728031cb	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	cefaaa17-f79a-4ba6-8f97-a59f60e07b75	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	0cd6e0e2-6b2c-4e0d-b5b2-ebfe0d5e31c4	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	96e78f74-fad0-4ae1-9e68-55e4c6ab2d60	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479 ndc (product): 63629-8476
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	03b1b0a9-0aa2-4039-acce-68ca54abaae4	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479 ndc (product): 63629-8474
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	a5417808-f767-48fc-9f5d-c1aeee4e57c3	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479 ndc (product): 63629-8475
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	a7553281-be90-47e3-8d2b-b027f6d18d3a	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	RADHA PHARMACEUTICALS, INC.	16a788ff-8bd5-4f70-a3fd-a89db019e435	2026-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479 ndc (product): 77771-144 ndc (product): 77771-145
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	ScieGen Pharmaceuticals,Inc.	05f82eca-cc87-4580-acd7-e6491c651881	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479 ndc (product): 50228-145 ndc (product): 50228-144
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Northwind Health Company, LLC	4ddf6ba2-c020-7912-e063-6394a90a7964	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	459bd1c9-d7a5-8bc9-e063-6394a90a8ecd	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	722650d8-5ee4-48ba-9827-7c86b1283522	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	16ffe2ac-4f71-4843-99df-611f53c2f3cd	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	3d826804-6427-aae1-e063-6394a90a6593	2025-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Quality Care Products, LLC	57a9f4d3-0c41-4978-b81e-cf3059bc8c42	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	0ac739de-ad59-4882-810e-f52db22ac96f	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	d6efb695-c439-48d7-a155-5c661a5049af	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Cipla USA., Inc.	0abd64f7-5142-48f6-a487-3f5bdc3400de	2023-10-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43598-655	Bupropion Hydrochloride	bupropion hydrochloride	Dr Reddys Laboratories Inc	ANDA	Current
43598-655	Bupropion Hydrochloride	bupropion hydrochloride	Dr Reddys Laboratories Inc	ANDA	Current
43598-655	Bupropion Hydrochloride	bupropion hydrochloride	Dr Reddys Laboratories Inc	ANDA	Current
43598-655	Bupropion Hydrochloride	bupropion hydrochloride	Dr Reddys Laboratories Inc	ANDA	Current
43598-655	Bupropion Hydrochloride	bupropion hydrochloride	Dr Reddys Laboratories Inc	ANDA	Current
43598-656	Bupropion Hydrochloride	bupropion hydrochloride	Dr Reddys Laboratories Inc	ANDA	Current
43598-656	Bupropion Hydrochloride	bupropion hydrochloride	Dr Reddys Laboratories Inc	ANDA	Current
43598-656	Bupropion Hydrochloride	bupropion hydrochloride	Dr Reddys Laboratories Inc	ANDA	Current
43598-656	Bupropion Hydrochloride	bupropion hydrochloride	Dr Reddys Laboratories Inc	ANDA	Current
43598-656	Bupropion Hydrochloride	bupropion hydrochloride	Dr Reddys Laboratories Inc	ANDA	Current
50228-144	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals,Inc.	ANDA	Current
50228-144	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals,Inc.	ANDA	Current
50228-144	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals,Inc.	ANDA	Current
50228-144	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals,Inc.	ANDA	Current
50228-144	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals,Inc.	ANDA	Current
50228-144	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals,Inc.	ANDA	Current
50228-145	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals,Inc.	ANDA	Current
50228-145	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals,Inc.	ANDA	Current
50228-145	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals,Inc.	ANDA	Current
50228-145	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals,Inc.	ANDA	Current
50228-145	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals,Inc.	ANDA	Current
50228-145	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals,Inc.	ANDA	Current
63629-8474	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8474	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8474	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8475	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8475	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8475	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8476	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8476	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8476	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
77771-144	Bupropion Hydrochloride	bupropion hydrochloride	RADHA PHARMACEUTICALS, INC.	ANDA	Current
77771-145	Bupropion Hydrochloride	bupropion hydrochloride	RADHA PHARMACEUTICALS, INC.	ANDA	Current