Application 075310

Type: ANDA
Sponsor: HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	TABLET;ORAL	75MG	No	No
002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A075310-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL			1999-11-29
A075310-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL			1999-11-29

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`3a93d1ddd44b…`

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 12 · 226 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Apotex Corp	86530199-999b-9f92-b1bc-b8515ec829f3	2026-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	136f29fa-a859-4efb-8365-1382716d6f8f	2026-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	81d251aa-a8e8-493e-94ed-12f6fb8902e6	2026-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Granules Pharmaceuticals Inc.	d9eb0939-63c1-48c4-a444-a899d7924d06	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	0b041720-a25d-403e-a72c-601a8bdd8051	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	b47c5515-a438-40bc-b8ad-26a6cf9676b7	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	6087100f-3ba4-412e-b08d-768d1dcdaf00	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	0aa86bd6-b37b-45f7-a837-b067e41184e9	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	bcbef1b4-a135-4231-bc65-7d0b335260e8	2026-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	56df4e22-81ca-48a4-a8e2-038448417355	2026-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	334e5635-e4cc-cf2a-e063-6294a90ae1e1	2026-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	0cd6e0e2-6b2c-4e0d-b5b2-ebfe0d5e31c4	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
bupropion hydrochloride SR	BUPROPION HYDROCHLORIDE	Cardinal Health 107, LLC	439a7e93-f578-434f-943f-4b93c35450f5	2026-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	5829a2aa-4845-b58b-e063-6294a90ad2f4	2026-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	4cc3327b-92c5-4667-ae16-3e95eafcf4d8	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	30c370c2-f2b7-4335-ba55-e8c8f4059092	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	080853c0-fcab-4645-9ddc-4946e895ac5f	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPROPION HYDROCHLORIDE generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Major Pharmaceuticals	aa3d3e5b-74a3-47f6-b9aa-d6e248e950e5	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Aurobindo Pharma Limited	cc344f7c-0eb3-4e63-a09e-b682acca2bb5	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPROPION HYDROCHLORIDE generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	c60855ca-4fa0-4004-ad19-4abb61100c43	2026-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53808-0213	Bupropion Hydrochloride	Bupropion Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44253	ORIG	2005-07-28