Application 076749

Type: ANDA
Sponsor: NEPHRON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE	SOLUTION;INHALATION	EQ 0.083% BASE;0.017%	No	No
002	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE	SOLUTION; INHALATION	0.5MG; 0.017%	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
A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076749-001	AN

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	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`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	A076749-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076749-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076749-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076749-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076749-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076749-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076749-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076749-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076749-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076749-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076749-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076749-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076749-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076749-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076749-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076749-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076749-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076749-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076749-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076749-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076749-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076749-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076749-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076749-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076749-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076749-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076749-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076749-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076749-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076749-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076749-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076749-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076749-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076749-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076749-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076749-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076749-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076749-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076749-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076749-001	AN	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ipratropium Bromide and Albuterol Sulfate	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	Rising Pharma Holdings, Inc.	3246dfab-61d7-27ba-e063-6294a90ac180	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076749 application number: ANDA076749
Ipratropium Bromide and Albuterol Sulfate	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	A-S Medication Solutions	65504330-6c02-4e30-9f32-51393e06f20c	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076749 application number: ANDA076749 ndc (product): 50090-1669
Ipratropium Bromide and Albuterol Sulfate	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	66f32a06-c880-4b5b-837b-951e1e01e040	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076749 application number: ANDA076749 ndc (product): 68788-8103
Ipratropium Bromide and Albuterol Sulfate	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	Chartwell RX, LLC	b444478a-10ce-484f-9039-6383dfb8161e	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076749 application number: ANDA076749
Ipratropium Bromide and Albuterol Sulfate	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	Nephron Pharmaceuticals Corporation	ae35ec1f-526a-49bf-8262-c50e40190d1f	2025-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076749 application number: ANDA076749 ndc (product): 0487-0201
Ipratropium Bromide and Albuterol Sulfate	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	Proficient Rx LP	a1d9d346-91a5-4f5a-82ed-4ebeaf350a06	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076749 application number: ANDA076749 ndc (product): 71205-051

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0487-0201	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	Nephron SC Inc.	ANDA	Current
0487-0201	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	Nephron Pharmaceuticals Corporation	ANDA	Current
50090-1669	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	A-S Medication Solutions	ANDA	Current
50090-1669	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	A-S Medication Solutions	ANDA	Current
50090-1669	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	A-S Medication Solutions	ANDA	Current
55154-4357	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	Cardinal Health	ANDA	Current
55154-4357	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	Cardinal Health	ANDA	Current
55154-4357	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	Cardinal Health	ANDA	Current
68788-7678	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-8103	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8103	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-2243	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-2250	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-2250	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-2250	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-2250	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	REMEDYREPACK INC.	ANDA	Current
71152-201	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	Medical Supply Distribution, Llc.	ANDA	Current
71205-051	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	Proficient Rx LP	ANDA	Current
71205-051	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	Proficient Rx LP	ANDA	Current
71205-051	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	Proficient Rx LP	ANDA	Current
71205-051	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	Proficient Rx LP	ANDA	Current
71205-051	Ipratropium Bromide and Albuterol Sulfate	Ipratropium Bromide and Albuterol Sulfate	Proficient Rx LP	ANDA	Current