Application 078060

Type: ANDA
Sponsor: CHARTWELL MOLECULES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	TABLET;ORAL	800MG;160MG	No	No
002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	TABLET;ORAL	400MG;80MG	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
A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB		2007-01-25
A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB		2007-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078060-001	AB
A078060-002	AB

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	Product TE source text	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2007-01-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2007-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2007-01-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2007-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2007-01-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2007-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2007-01-25	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2007-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2007-01-25	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2007-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2007-01-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2007-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2007-01-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2007-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2007-01-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2007-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2007-01-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2007-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2007-01-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2007-01-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2007-01-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2007-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2007-01-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2007-01-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2007-01-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2007-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2007-01-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2007-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2007-01-25	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2007-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2007-01-25	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2007-01-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2007-01-25	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2007-01-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2007-01-25	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2007-01-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2007-01-25	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2007-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078060-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2007-01-25	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078060-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2007-01-25	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A078060-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078060-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078060-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078060-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078060-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078060-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078060-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078060-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078060-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078060-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078060-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078060-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078060-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078060-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078060-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078060-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078060-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078060-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078060-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078060-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078060-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078060-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078060-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078060-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078060-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078060-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078060-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078060-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078060-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078060-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078060-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078060-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078060-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078060-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078060-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078060-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078060-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078060-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078060-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078060-002	AB	1	`4b0b4de00fa7…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Chartwell RX, LLC	e4a7572f-b372-40eb-963f-919ac100b7a8	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078060 application number: ANDA078060

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43353-368	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
55695-008	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Department of State Health Services, Pharmacy Branch	ANDA	Current
63187-285	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Proficient Rx LP	ANDA	Current
67046-715	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Contract Pharmacy Services-PA	ANDA	Current
68788-9086	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Preferred Pharmaceuticals	ANDA	Current
68788-9086	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Preferred Pharmaceuticals, Inc	ANDA	Current
75921-578	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Life Line Home Care Services, Inc.	ANDA	Current