Application 017377

Type: NDA
Sponsor: SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BACTRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	TABLET;ORAL	400MG;80MG	Yes	No
002	BACTRIM DS	SULFAMETHOXAZOLE; TRIMETHOPRIM	TABLET;ORAL	800MG;160MG	Yes	Yes

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
N017377-001	BACTRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982
N017377-002	BACTRIM DS	SULFAMETHOXAZOLE; TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017377-001	AB
N017377-002	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	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N017377-001	BACTRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017377-002	BACTRIM DS	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017377-001	BACTRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017377-002	BACTRIM DS	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017377-001	BACTRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017377-002	BACTRIM DS	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017377-001	BACTRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017377-002	BACTRIM DS	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017377-001	BACTRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017377-002	BACTRIM DS	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017377-001	BACTRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017377-002	BACTRIM DS	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017377-001	BACTRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017377-002	BACTRIM DS	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017377-001	BACTRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017377-002	BACTRIM DS	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017377-001	BACTRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017377-002	BACTRIM DS	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017377-001	BACTRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017377-002	BACTRIM DS	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017377-001	BACTRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017377-002	BACTRIM DS	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017377-001	BACTRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N017377-002	BACTRIM DS	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017377-001	BACTRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N017377-002	BACTRIM DS	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017377-001	BACTRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017377-002	BACTRIM DS	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017377-001	BACTRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017377-002	BACTRIM DS	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017377-001	BACTRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017377-002	BACTRIM DS	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017377-001	BACTRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017377-002	BACTRIM DS	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017377-001	BACTRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N017377-002	BACTRIM DS	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017377-001	BACTRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N017377-002	BACTRIM DS	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017377-001	BACTRIM	400MG;80MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017377-002	BACTRIM DS	800MG;160MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`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	N017377-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017377-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N017377-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017377-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017377-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017377-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017377-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017377-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017377-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017377-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017377-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017377-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017377-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017377-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017377-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017377-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017377-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017377-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017377-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017377-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017377-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017377-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017377-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017377-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017377-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017377-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017377-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017377-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017377-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017377-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017377-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017377-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017377-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017377-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017377-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017377-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017377-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017377-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017377-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017377-002	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
Bactrim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Sun Pharmaceutical Industries, Inc	f59d0c04-9c66-4d53-a0e1-cb55570deb62	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017377 application number: NDA017377 ndc (product): 49708-145 ndc (product): 49708-146

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49708-145	Bactrim	sulfamethoxazole and Trimethoprim	Sun Pharmaceutical Industries, Inc	NDA	Current
49708-145	Bactrim	sulfamethoxazole and Trimethoprim	Sun Pharmaceutical Industries, Inc	NDA	Current
49708-145	Bactrim	sulfamethoxazole and Trimethoprim	Sun Pharmaceutical Industries, Inc	NDA	Current
49708-145	Bactrim	sulfamethoxazole and Trimethoprim	Sun Pharmaceutical Industries, Inc	NDA	Current
49708-145	Bactrim	sulfamethoxazole and Trimethoprim	Sun Pharmaceutical Industries, Inc	NDA	Current
49708-146	Bactrim DS	sulfamethoxazole and Trimethoprim	Sun Pharmaceutical Industries, Inc	NDA	Current
49708-146	Bactrim DS	sulfamethoxazole and Trimethoprim	Sun Pharmaceutical Industries, Inc	NDA	Current
49708-146	Bactrim DS	sulfamethoxazole and Trimethoprim	Sun Pharmaceutical Industries, Inc	NDA	Current
49708-146	Bactrim DS	sulfamethoxazole and Trimethoprim	Sun Pharmaceutical Industries, Inc	NDA	Current
49708-146	Bactrim DS	sulfamethoxazole and Trimethoprim	Sun Pharmaceutical Industries, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81349	SUPPL	2025-02-25
81326	SUPPL	2025-02-24
78892	SUPPL	2024-06-25
78888	SUPPL	2024-06-25
67429	SUPPL	2021-05-06
67388	SUPPL	2021-05-04
64142	SUPPL	2020-07-30
64118	SUPPL	2020-07-29
33251	SUPPL	2014-07-17
13119	SUPPL	2014-07-17
10978	SUPPL	2013-07-17
10977	SUPPL	2013-07-17
13118	SUPPL	2013-07-15
13117	SUPPL	2013-07-15
33250	SUPPL	2012-08-31
569	SUPPL	2012-08-31
33249	SUPPL	2010-07-31
13116	SUPPL	2010-07-29
13115	SUPPL	2010-07-02
33248	SUPPL	2007-06-07
568	SUPPL	2007-06-07
33247	SUPPL	2003-02-12
567	SUPPL	2003-02-12
13114	SUPPL	2002-10-17
10976	SUPPL	2002-10-17