Application 211832

Type: ANDA
Sponsor: TWI PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TERBUTALINE SULFATE	TERBUTALINE SULFATE	TABLET;ORAL	2.5MG	No	No
002	TERBUTALINE SULFATE	TERBUTALINE SULFATE	TABLET;ORAL	5MG	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
A211832-001	TERBUTALINE SULFATE	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2020-06-19
A211832-002	TERBUTALINE SULFATE	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB		2020-06-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211832-001	AB
A211832-002	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 1 of 2 · 74 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	A211832-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB	2020-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211832-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	2020-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211832-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB	2020-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211832-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	2020-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211832-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB	2020-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211832-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	2020-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211832-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB	2020-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211832-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	2020-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211832-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB	2020-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211832-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	2020-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211832-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB	2020-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211832-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	2020-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211832-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB	2020-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211832-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	2020-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211832-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB	2020-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211832-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	2020-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211832-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB	2020-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211832-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	2020-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211832-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB	2020-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211832-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	2020-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211832-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB	2020-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211832-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	2020-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211832-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB	2020-06-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211832-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	2020-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211832-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB	2020-06-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211832-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	2020-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211832-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB	2020-06-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211832-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	2020-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211832-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB	2020-06-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211832-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	2020-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211832-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB	2020-06-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211832-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	2020-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211832-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB	2020-06-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211832-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	2020-06-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211832-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB	2020-06-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211832-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	2020-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211832-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB	2020-06-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211832-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	2020-06-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211832-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB	2020-06-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211832-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	2020-06-19	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A211832-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211832-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211832-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211832-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211832-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211832-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211832-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211832-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211832-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211832-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211832-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211832-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211832-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211832-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211832-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211832-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211832-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211832-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211832-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211832-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211832-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211832-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211832-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211832-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211832-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211832-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211832-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211832-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211832-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211832-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211832-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211832-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211832-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211832-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211832-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211832-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211832-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211832-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211832-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211832-002	AB	1	`87673890dc5c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terbutaline Sulfate	TERBUTALINE SULFATE	Upsher-Smith Laboratories, LLC	3a4e5046-293c-4616-8679-6da65f31626b	2025-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211832 application number: ANDA211832 ndc (product): 24979-132 ndc (product): 24979-133
Terbutaline Sulfate	TERBUTALINE SULFATE	Proficient Rx LP	0a95bc4f-34d3-4b5e-841b-6839e1c1e0c7	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211832 application number: ANDA211832 ndc (product): 71205-939 ndc (product): 71205-938

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
24979-132	Terbutaline Sulfate	Terbutaline Sulfate	TWi Pharmaceuticals, Inc.	ANDA	Current
24979-133	Terbutaline Sulfate	Terbutaline Sulfate	TWi Pharmaceuticals, Inc.	ANDA	Current
71205-938	Terbutaline Sulfate	Terbutaline Sulfate	Proficient Rx LP	ANDA	Current
71205-938	Terbutaline Sulfate	Terbutaline Sulfate	Proficient Rx LP	ANDA	Current
71205-939	Terbutaline Sulfate	Terbutaline Sulfate	Proficient Rx LP	ANDA	Current
71205-939	Terbutaline Sulfate	Terbutaline Sulfate	Proficient Rx LP	ANDA	Current