Application 076770

Type: ANDA
Sponsor: ATHENEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TERBUTALINE SULFATE	TERBUTALINE SULFATE	INJECTABLE;INJECTION	1MG/ML	No	Yes

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
A076770-001	TERBUTALINE SULFATE	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION			2004-04-23

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION			2004-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION			2004-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION			2004-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION			2004-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION			2004-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION			2004-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076770-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2004-04-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076770-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076770-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076770-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076770-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076770-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076770-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076770-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076770-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076770-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076770-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076770-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076770-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076770-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076770-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076770-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076770-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076770-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076770-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076770-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076770-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076770-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076770-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076770-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076770-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076770-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076770-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076770-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076770-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076770-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076770-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076770-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076770-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076770-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076770-001	AP	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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terbutaline Sulfate	TERBUTALINE SULFATE	Chartwell RX, LLC.	859267c6-3d14-4123-9b9d-4fc248f09726	2025-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Terbutaline Sulfate generic name: TERBUTALINE SULFATE
Terbutaline Sulfate	TERBUTALINE SULFATE	Upsher-Smith Laboratories, LLC	3a4e5046-293c-4616-8679-6da65f31626b	2025-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Terbutaline Sulfate generic name: TERBUTALINE SULFATE
TERBUTALINE SULFATE	TERBUTALINE SULFATE	Amneal Pharmaceuticals of New York LLC	382dcebb-6e41-4335-818d-b5822e3fb884	2025-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TERBUTALINE SULFATE generic name: TERBUTALINE SULFATE
Terbutaline Sulfate	TERBUTALINE SULFATE	Henry Schein, Inc.	9f4b177e-4d7d-4255-afeb-522c7d4594c6	2025-07-16	Warnings, Adverse reactions	Name fallback brand name: Terbutaline Sulfate generic name: TERBUTALINE SULFATE
Terbutaline Sulfate	TERBUTALINE SULFATE	Hikma Pharmaceuticals USA Inc.	613df3cb-4d55-4d12-ab08-a932481aaa0b	2024-01-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Terbutaline Sulfate generic name: TERBUTALINE SULFATE
Terbutaline Sulfate	TERBUTALINE SULFATE	Medical Purchasing Solutions. LLC	6a22b62c-4ee1-49df-e053-2a91aa0a3e52	2023-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Terbutaline Sulfate generic name: TERBUTALINE SULFATE
Terbutaline Sulfate	TERBUTALINE SULFATE	Fresenius Kabi USA, LLC	cec31032-f366-4524-9e01-63146e473b2b	2022-07-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Terbutaline Sulfate generic name: TERBUTALINE SULFATE
Terbutaline Sulfate	TERBUTALINE SULFATE	Proficient Rx LP	0a95bc4f-34d3-4b5e-841b-6839e1c1e0c7	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Terbutaline Sulfate generic name: TERBUTALINE SULFATE
Terbutaline Sulfate	TERBUTALINE SULFATE	Lannett Company, Inc.	fbf54709-5857-4dbc-9233-ebd7abff88c8	2020-11-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Terbutaline Sulfate generic name: TERBUTALINE SULFATE
Terbutaline Sulfate	TERBUTALINE SULFATE	Hikma Pharmaceuticals USA Inc.	0f4d3249-e022-40b6-b93d-f605e8522207	2020-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Terbutaline Sulfate generic name: TERBUTALINE SULFATE
Terbutaline Sulfate	TERBUTALINE SULFATE	ANI Pharmaceuticals, Inc.	d810a15b-3e10-4f6c-a36e-8ddecbaba9c3	2019-11-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Terbutaline Sulfate generic name: TERBUTALINE SULFATE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23836	ORIG	2011-02-17
8959	ORIG	2004-04-29