Application 075808

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRI-SPRINTEC	ETHINYL ESTRADIOL; NORGESTIMATE	TABLET;ORAL-28	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075808-001	TRI-SPRINTEC	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB		2003-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075808-001	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 2 · 41 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	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075808-001	TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2003-12-29	`cb3db0bc1861…`

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	A075808-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075808-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075808-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075808-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075808-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075808-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075808-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075808-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075808-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075808-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075808-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075808-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075808-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075808-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075808-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075808-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075808-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075808-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075808-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075808-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075808-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075808-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075808-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075808-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075808-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075808-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075808-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075808-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075808-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075808-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075808-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075808-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075808-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075808-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075808-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075808-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075808-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075808-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075808-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075808-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tri-Sprintec	NORGESTIMATE AND ETHINYL ESTRADIOL	Preferred Pharmaceuticals Inc.	1f8b9aad-f31f-4cda-861d-c08a977fc923	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075808 application number: ANDA075808 ndc (product): 68788-6325
Tri-Sprintec	NORGESTIMATE AND ETHINYL ESTRADIOL	Teva Pharmaceuticals USA, Inc.	843cbef6-cbfb-4a44-bb80-22930753e4c0	2025-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075808 application number: ANDA075808 ndc (product): 0555-9018
Tri-Sprintec	NORGESTIMATE AND ETHINYL ESTRADIOL	Proficient Rx LP	c1fc22e5-e02d-4dda-a9ac-c592e922c467	2020-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075808 application number: ANDA075808 ndc (product): 63187-458

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0555-9018	Tri-Sprintec	norgestimate and ethinyl estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9018	Tri-Sprintec	norgestimate and ethinyl estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9018	Tri-Sprintec	norgestimate and ethinyl estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9018	Tri-Sprintec	norgestimate and ethinyl estradiol	Teva Pharmaceuticals USA,	ANDA	Current
21695-770	Tri-Sprintec	norgestimate and ethinyl estradiol	Rebel Distributors Corp	ANDA	Current
63187-458	Tri-Sprintec	norgestimate and ethinyl estradiol	Proficient Rx LP	ANDA	Current
63187-458	Tri-Sprintec	norgestimate and ethinyl estradiol	Proficient Rx LP	ANDA	Current
63629-8751	Tri-Sprintec	norgestimate and ethinyl estradiol	Bryant Ranch Prepack	ANDA	Current
63629-8751	Tri-Sprintec	norgestimate and ethinyl estradiol	Bryant Ranch Prepack	ANDA	Current
63629-8751	Tri-Sprintec	norgestimate and ethinyl estradiol	Bryant Ranch Prepack	ANDA	Current
66116-436	Tri-Sprintec	norgestimate and ethinyl estradiol	MedVantx, Inc.	ANDA	Current
68788-6325	Tri-Sprintec	norgestimate and ethinyl estradiol	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6325	Tri-Sprintec	norgestimate and ethinyl estradiol	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6325	Tri-Sprintec	norgestimate and ethinyl estradiol	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6325	Tri-Sprintec	norgestimate and ethinyl estradiol	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6325	Tri-Sprintec	norgestimate and ethinyl estradiol	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0842	Tri-Sprintec	norgestimate and ethinyl estradiol	REMEDYREPACK INC.	ANDA	Current
70518-0842	Tri-Sprintec	norgestimate and ethinyl estradiol	REMEDYREPACK INC.	ANDA	Current
70518-0842	Tri-Sprintec	norgestimate and ethinyl estradiol	REMEDYREPACK INC.	ANDA	Current
70518-0842	Tri-Sprintec	norgestimate and ethinyl estradiol	REMEDYREPACK INC.	ANDA	Current
70518-0842	Tri-Sprintec	norgestimate and ethinyl estradiol	REMEDYREPACK INC.	ANDA	Current
70518-0842	Tri-Sprintec	norgestimate and ethinyl estradiol	REMEDYREPACK INC.	ANDA	Current
76413-128	Tri-Sprintec	norgestimate and ethinyl estradiol	Central Texas Community Health Centers	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22504	ORIG	2007-07-06