Application 018615

Type: NDA
Sponsor: PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SULFATRIM PEDIATRIC	SULFAMETHOXAZOLE; TRIMETHOPRIM	SUSPENSION;ORAL	200MG/5ML;40MG/5ML	No	No
002	SULFATRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	SUSPENSION;ORAL	200MG/5ML;40MG/5ML	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
N018615-001	SULFATRIM PEDIATRIC	SULFAMETHOXAZOLE; TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		1983-01-07
N018615-002	SULFATRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL			1983-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018615-001	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 1 of 3 · 82 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	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N018615-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018615-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018615-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018615-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018615-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018615-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018615-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018615-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018615-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018615-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018615-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018615-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018615-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018615-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018615-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018615-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018615-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018615-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018615-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018615-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018615-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018615-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018615-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018615-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018615-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018615-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018615-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018615-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018615-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018615-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018615-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018615-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018615-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018615-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018615-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018615-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018615-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018615-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018615-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018615-001	AB	1	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SULFATRIM	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	80f7f00b-add4-4d6b-9e9c-bea29768c239	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018615 application number: NDA018615
SULFATRIM	SULFAMETHOXAZOLE AND TRIMETHOPRIM	PAI Holdings, LLC dba PAI Pharma	c62086ea-ba15-40f5-8431-4639c60c9825	2025-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018615 application number: NDA018615 ndc (product): 0121-0854
SULFATRIM	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Preferred Pharmaceuticals, Inc.	cd4932ce-0856-4e99-8baf-70afce1d7ffd	2025-01-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018615 application number: NDA018615 ndc (product): 68788-7345
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	PAI Holdings, LLC dba PAI Pharma	777da85a-a776-4681-976d-326ec421cfc9	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018615 application number: NDA018615 ndc (product): 0121-0853

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-0853	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Pharmaceutical Associates, Inc.	NDA	Current
0121-0853	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Pharmaceutical Associates, Inc.	NDA	Current
0121-0853	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Pharmaceutical Associates, Inc.	NDA	Current
0121-0854	SULFATRIM	Sulfamethoxazole and Trimethoprim	Pharmaceutical Associates, Inc.	NDA	Current
0121-0854	SULFATRIM	Sulfamethoxazole and Trimethoprim	Pharmaceutical Associates, Inc.	NDA	Current
0121-0854	SULFATRIM	Sulfamethoxazole and Trimethoprim	Pharmaceutical Associates, Inc.	NDA	Current
0121-0854	SULFATRIM	Sulfamethoxazole and Trimethoprim	Pharmaceutical Associates, Inc.	NDA	Current
17856-0007	SULFATRIM	Sulfamethoxazole and Trimethoprim	Atlantic Biologicals Corps	NDA	Current
54879-007	SULFATRIM	Sulfamethoxazole and Trimethoprim	STI Pharma LLC	NDA	Current
67296-1163	SULFATRIM	SULFATRIM	RedPharm Drug, Inc.	NDA	Current
67296-1163	SULFATRIM	SULFATRIM	RedPharm Drug, Inc.	NDA	Current
67296-1657	SULFATRIM	Sulfamethoxazole and Trimethoprim	RedPharm Drug, Inc.	NDA	Current
67296-1657	SULFATRIM	Sulfamethoxazole and Trimethoprim	RedPharm Drug, Inc.	NDA	Current
68788-7083	SULFATRIM	Sulfamethoxazole and Trimethoprim	Preferred Pharmaceuticals Inc.	NDA	Current
68788-7083	SULFATRIM	Sulfamethoxazole and Trimethoprim	Preferred Pharmaceuticals	NDA	Current
68788-7345	SULFATRIM	Sulfamethoxazole and Trimethoprim	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7345	SULFATRIM	Sulfamethoxazole and Trimethoprim	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7345	SULFATRIM	Sulfamethoxazole and Trimethoprim	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7345	SULFATRIM	Sulfamethoxazole and Trimethoprim	Preferred Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81353	SUPPL	2025-02-25
81328	SUPPL	2025-02-24
78894	SUPPL	2024-06-25
78890	SUPPL	2024-06-25
69020	SUPPL	2021-10-19
69012	SUPPL	2021-10-18