Application 076130

Type: ANDA
Sponsor: DAVA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	VOSPIRE ER	ALBUTEROL SULFATE	TABLET, EXTENDED RELEASE;ORAL	EQ 4MG BASE	No	No
003	VOSPIRE ER	ALBUTEROL SULFATE	TABLET, EXTENDED RELEASE;ORAL	EQ 8MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A076130-002	VOSPIRE ER	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2002-09-26
A076130-003	VOSPIRE ER	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2002-09-26

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 · 86 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
2026-09-14 22:38:34	2026-08	A076130-002	VOSPIRE ER	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076130-003	VOSPIRE ER	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076130-002	VOSPIRE ER	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076130-003	VOSPIRE ER	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076130-002	VOSPIRE ER	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076130-003	VOSPIRE ER	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076130-002	VOSPIRE ER	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076130-003	VOSPIRE ER	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076130-002	VOSPIRE ER	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076130-003	VOSPIRE ER	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076130-002	VOSPIRE ER	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076130-003	VOSPIRE ER	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076130-002	VOSPIRE ER	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076130-003	VOSPIRE ER	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076130-002	VOSPIRE ER	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076130-003	VOSPIRE ER	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076130-002	VOSPIRE ER	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076130-003	VOSPIRE ER	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076130-002	VOSPIRE ER	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076130-003	VOSPIRE ER	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076130-002	VOSPIRE ER	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076130-003	VOSPIRE ER	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076130-002	VOSPIRE ER	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076130-003	VOSPIRE ER	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076130-002	VOSPIRE ER	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076130-003	VOSPIRE ER	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076130-002	VOSPIRE ER	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076130-003	VOSPIRE ER	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076130-002	VOSPIRE ER	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076130-003	VOSPIRE ER	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076130-002	VOSPIRE ER	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076130-003	VOSPIRE ER	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076130-002	VOSPIRE ER	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076130-003	VOSPIRE ER	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076130-002	VOSPIRE ER	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076130-003	VOSPIRE ER	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076130-002	VOSPIRE ER	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076130-003	VOSPIRE ER	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076130-002	VOSPIRE ER	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-09-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076130-003	VOSPIRE ER	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-26	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076130-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076130-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076130-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076130-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076130-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076130-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076130-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076130-002	AB	1	`ea99ee380514…`

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 2 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Albuterol Sulfate	ALBUTEROL SULFATE	Sun Pharmaceutical Industries, Inc.	bb538b7d-e390-419a-9404-a57c1db4a447	2026-04-09	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Cardinal Health 107, LLC	6ec88f64-66a2-4ca9-9913-c192fc33f88b	2026-04-08	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Nephron Pharmaceuticals Corporation	285a656c-f77f-4e77-b0a8-a0e9c901803f	2026-04-06	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
albuterol sulfate	ALBUTEROL SULFATE	Sun Pharmaceutical Industries, Inc.	87b8cd3c-2849-4b50-b63e-9ea379165c07	2026-03-16	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	c90e80b2-882e-4c0c-bfac-d67eb1da724d	2026-02-16	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Mylan Pharmaceuticals Inc.	5329614f-ae0b-4854-bb6f-ea0b7dae87c0	2026-02-10	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulate HFA	ALBUTEROL SULFATE	REMEDYREPACK INC.	77d34a3c-ccc6-420a-ad31-a1af55f7de76	2026-01-30	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	1f0bf143-66d4-4a39-b2d1-a5c460ffdcf9	2026-01-22	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
VENTOLIN HFA	ALBUTEROL SULFATE	REMEDYREPACK INC.	2ed73618-be3a-4331-9509-6401258f791f	2026-01-19	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	5de6a189-a8b7-4b33-b162-add6b6e4b275	2026-01-16	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	d6acb5a7-555a-463a-ae65-2911d6789b42	2026-01-14	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol	ALBUTEROL SULFATE	Cipla USA Inc.	fd0389e0-3713-42e0-8ef2-3bb97676fded	2026-01-04	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	Chartwell Governmental & Specialty RX, LLC.	dd47559a-84f6-42a5-a00e-48754505418e	2025-12-17	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Sandoz Inc	f8a2c4b7-a162-48ab-90b0-350e4da25c66	2025-12-16	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	Bryant Ranch Prepack	378461f2-7271-44a3-9da3-b39970b65d3a	2025-11-10	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Nephron Pharmaceuticals Corporation	574824f3-51cc-4b94-9c10-e3204d8b19f8	2025-11-07	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	ASCLEMED USA INC.	8ea40065-4f59-434f-9ea1-7ef006fde66e	2025-11-07	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Asclemed USA, Inc.	056e145b-87aa-4009-a7ab-2ac0bd086eb0	2025-11-06	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	NuCare Pharmaceuticals, Inc.	2c3f975c-dbd8-0362-e063-6394a90a16dd	2025-10-21	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	4120061a-dbae-8918-e063-6394a90afbf2	2025-10-14	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43055	ORIG	2007-07-06