Application 205794

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	100MG	No	No
002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	150MG	No	No
003	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	200MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205794-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01
A205794-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01
A205794-003	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A205794-001	AB1
A205794-002	AB1
A205794-003	AB1

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205794-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205794-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205794-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205794-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205794-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205794-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205794-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205794-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205794-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205794-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205794-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205794-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205794-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205794-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205794-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205794-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205794-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205794-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205794-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205794-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205794-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205794-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205794-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205794-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205794-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205794-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205794-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205794-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205794-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205794-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205794-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205794-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205794-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205794-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205794-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205794-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205794-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205794-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205794-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205794-001	AB1	1	`8072bd15b7f6…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	c76f2f9f-3999-4bdd-8ec3-e0066318d378	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Northwind Health Company, LLC	0865f8cf-1d7f-0e67-e063-6294a90a2f4d	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	6701af43-bf7d-45c4-a331-a18d16bd68f7	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794 ndc (product): 71335-1984
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	21be6b3b-add3-43e7-af93-30350aefc89e	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794 ndc (product): 71335-1866
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	a72db723-df4b-4bf4-9bdc-05ae82058696	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794 ndc (product): 71335-1702
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	c37bb183-f272-4cae-96e1-7042c1dd7bcf	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794 ndc (product): 63629-8473
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	fd153957-ff74-4134-8545-cdc0e5619906	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	c0445fea-108f-4e00-a2ae-ebbdf2719947	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794 ndc (product): 68788-7793
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	d1d1ed19-e111-4652-a0d4-9406e6f73e9f	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794 ndc (product): 68788-7819
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	0b33fb1f-a7f0-4ab7-a882-eca2d2c77afa	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794 ndc (product): 68788-7807
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	b47c5515-a438-40bc-b8ad-26a6cf9676b7	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4bd469b8-fb35-0223-e063-6294a90ae7bc	2026-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	9d0608a1-0cc8-491a-ad91-238e0ea009fe	2026-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794 ndc (product): 72789-158
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Dr. Reddys Laboratories Inc.	ad784c8e-7201-4336-a310-616e3e979ca4	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794 ndc (product): 43598-753 ndc (product): 43598-752 ndc (product): 43598-751
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc.	092da413-ec60-4577-ac57-51e3e42d55c9	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794 ndc (product): 50228-175 ndc (product): 50228-174 ndc (product): 50228-176
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Radha Pharmaceuticals, Inc.	161637d2-bc9d-4a2b-ad1f-6cc39ffd69ce	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794 ndc (product): 77771-175 ndc (product): 77771-174
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	eeb3fed1-2202-09fc-e053-2995a90a9f63	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794 ndc (product): 68071-2890
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Proficient Rx LP	1094ff8e-f5a5-4a72-8bf9-25e68f5c964a	2025-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794 ndc (product): 71205-550
BUPROPION HYDROCHLORIDE SR	BUPROPION HYDROCHLORIDE SR	DirectRx	dd4041cd-00e4-d10f-e053-2a95a90a5945	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794 ndc (product): 72189-349
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	339c7157-1c65-40d1-bbcc-c10348d908d3	2024-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 81 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43598-536	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-536	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-536	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-537	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-537	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-537	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-538	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-538	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-538	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-751	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-751	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-751	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-751	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-751	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-752	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-752	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-752	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-752	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-752	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-753	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-753	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-753	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-753	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
43598-753	Bupropion Hydrochloride	bupropion hydrochloride	Dr. Reddy	ANDA	Current
50228-174	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-174	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-174	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-174	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-174	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-175	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-175	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-175	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-175	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-175	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-176	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-176	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-176	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-176	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-176	Bupropion Hydrochloride	bupropion hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
63629-8473	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8473	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
68071-1573	Bupropion Hydrochloride	bupropion hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2890	Bupropion Hydrochloride	bupropion hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2890	Bupropion Hydrochloride	bupropion hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7174	Bupropion Hydrochloride	bupropion hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7174	Bupropion Hydrochloride	bupropion hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7174	Bupropion Hydrochloride	bupropion hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7793	Bupropion Hydrochloride	bupropion hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7793	Bupropion Hydrochloride	bupropion hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7793	Bupropion Hydrochloride	bupropion hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7807	Bupropion Hydrochloride	bupropion hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7807	Bupropion Hydrochloride	bupropion hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7807	Bupropion Hydrochloride	bupropion hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7819	Bupropion Hydrochloride	bupropion hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7819	Bupropion Hydrochloride	bupropion hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7819	Bupropion Hydrochloride	bupropion hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
70934-791	Bupropion Hydrochloride	bupropion hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-791	Bupropion Hydrochloride	bupropion hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-791	Bupropion Hydrochloride	bupropion hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-928	Bupropion Hydrochloride	bupropion hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-550	Bupropion Hydrochloride	bupropion hydrochloride	Proficient Rx LP	ANDA	Current
71205-550	Bupropion Hydrochloride	bupropion hydrochloride	Proficient Rx LP	ANDA	Current
71335-1702	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1702	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1702	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1866	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1866	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1984	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1984	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71610-570	Bupropion Hydrochloride	bupropion hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-576	Bupropion Hydrochloride	bupropion hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-576	Bupropion Hydrochloride	bupropion hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-582	Bupropion Hydrochloride	bupropion hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-582	Bupropion Hydrochloride	bupropion hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72189-349	BUPROPION HYDROCHLORIDE SR	BUPROPION HYDROCHLORIDE SR	DirectRx	ANDA	Current
72189-349	BUPROPION HYDROCHLORIDE SR	BUPROPION HYDROCHLORIDE SR	DirectRx	ANDA	Current
72789-158	Bupropion Hydrochloride	bupropion hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-158	Bupropion Hydrochloride	bupropion hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
77771-174	Bupropion Hydrochloride	bupropion hydrochloride	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-175	Bupropion Hydrochloride	bupropion hydrochloride	Radha Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10503	ORIG	2016-03-03