Application 078630

Type: ANDA
Sponsor: HIKMA FARMACEUTICA

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	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078630-001	TERBUTALINE SULFATE	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2009-05-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078630-001	AP

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 · 42 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
2026-08-18 06:07:40	2026-07	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2009-05-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2009-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2009-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2009-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2009-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2009-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2009-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078630-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078630-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078630-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078630-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078630-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078630-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078630-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078630-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078630-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078630-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078630-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078630-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078630-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078630-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078630-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078630-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078630-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078630-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078630-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078630-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078630-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078630-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078630-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078630-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078630-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078630-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078630-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078630-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078630-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078630-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078630-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078630-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078630-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078630-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078630-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078630-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078630-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078630-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078630-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078630-001	AP	1	`e64feba35796…`

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
Terbutaline Sulfate	TERBUTALINE SULFATE	Hikma Pharmaceuticals USA Inc.	613df3cb-4d55-4d12-ab08-a932481aaa0b	2024-01-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078630 application number: ANDA078630 ndc (product): 0143-9746
Terbutaline Sulfate	TERBUTALINE SULFATE	Medical Purchasing Solutions. LLC	6a22b62c-4ee1-49df-e053-2a91aa0a3e52	2023-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078630 application number: ANDA078630 ndc (product): 71872-7080
Terbutaline Sulfate	TERBUTALINE SULFATE	Hikma Pharmaceuticals USA Inc.	0f4d3249-e022-40b6-b93d-f605e8522207	2020-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078630 application number: ANDA078630 ndc (product): 0143-9375

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9375	Terbutaline Sulfate	Terbutaline Sulfate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9375	Terbutaline Sulfate	Terbutaline Sulfate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9746	Terbutaline Sulfate	Terbutaline Sulfate	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9746	Terbutaline Sulfate	Terbutaline Sulfate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
71872-7080	Terbutaline Sulfate	Terbutaline Sulfate	Medical Purchasing Solutions. LLC	ANDA	Current
71872-7080	Terbutaline Sulfate	Terbutaline Sulfate	Medical Purchasing Solutions. LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23914	ORIG	2011-02-17