Application 078949

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUDESONIDE	BUDESONIDE	SPRAY, METERED;NASAL	0.032MG/INH	No	No
002	BUDESONIDE	BUDESONIDE	SPRAY, METERED;NASAL	0.032MG/SPRAY	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
A078949-002	BUDESONIDE	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL			2015-11-20

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`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
Budesonide	BUDESONIDE	Rugby Laboratories	04eb9e98-1323-353f-3fd7-2d317dfac526	2026-02-27	Warnings	Exact identifier application applno (ANDA): 078949 application number: ANDA078949 ndc (product): 0536-1112
Budesonide	BUDESONIDE	Walgreens	9d519bf3-8d9b-5208-13c5-308edc24aca7	2026-01-21	Warnings	Exact identifier application applno (ANDA): 078949 application number: ANDA078949 ndc (product): 0363-0048
Budesonide	BUDESONIDE	CVS Pharmacy	b2650d29-c011-48f1-a7f4-040011d4563d	2026-01-21	Warnings	Exact identifier application applno (ANDA): 078949 application number: ANDA078949 ndc (product): 69842-001
Budesonide	BUDESONIDE	Rugby Laboratories	b83af99e-1619-48ed-a033-e5207033f77e	2025-12-09	Warnings	Exact identifier application applno (ANDA): 078949 application number: ANDA078949
Budesonide	BUDESONIDE	Apotex Corp.	f1aac35a-bc72-dd68-8179-8661354589cb	2025-09-22	Warnings	Exact identifier application applno (ANDA): 078949 application number: ANDA078949 ndc (product): 60505-6129
Budesonide	BUDESONIDE	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	d9ba3859-90af-0390-11be-c04834e27d61	2025-05-16	Warnings	Exact identifier application applno (ANDA): 078949 application number: ANDA078949 ndc (product): 49035-703

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0048	Budesonide	Budesonide	Walgreens	ANDA	Current
0363-0048	Budesonide	Budesonide	Walgreens	ANDA	Current
0363-0048	Budesonide	Budesonide	Walgreens	ANDA	Current
0363-0048	Budesonide	Budesonide	Walgreens	ANDA	Current
0536-1112	Budesonide	Budesonide	Rugby Laboratories	ANDA	Current
0536-1112	Budesonide	Budesonide	Rugby Laboratories	ANDA	Current
0536-1112	Budesonide	Budesonide	Rugby Laboratories	ANDA	Current
0536-1112	Budesonide	Budesonide	Rugby Laboratories	ANDA	Current
0536-1112	Budesonide	Budesonide	Rugby Laboratories	ANDA	Current
11822-1700	Budesonide	Budesonide	Rite Aid	ANDA	Current
11822-1700	Budesonide	Budesonide	Rite Aid	ANDA	Current
11822-1700	Budesonide	Budesonide	Rite Aid	ANDA	Current
11822-1700	Budesonide	Budesonide	Rite Aid	ANDA	Current
11822-6000	Budesonide	Budesonide	Rite Aid	ANDA	Current
21130-710	Budesonide	Budesonide	Safeway	ANDA	Current
21130-710	Budesonide	Budesonide	Safeway	ANDA	Current
21130-710	Budesonide	Budesonide	Safeway	ANDA	Current
36800-113	Budesonide	Budesonide	Topco Associates LLC	ANDA	Current
36800-113	Budesonide	Budesonide	Topco Associates LLC	ANDA	Current
36800-113	Budesonide	Budesonide	Topco Associates LLC	ANDA	Current
46122-389	Budesonide	Budesonide	Amerisource Bergen	ANDA	Current
46122-389	Budesonide	Budesonide	Amerisource Bergen	ANDA	Current
46122-389	Budesonide	Budesonide	Amerisource Bergen	ANDA	Current
46122-389	Budesonide	Budesonide	Amerisource Bergen	ANDA	Current
49035-703	Budesonide	Budesonide	Walmart	ANDA	Current
49035-703	Budesonide	Budesonide	Walmart	ANDA	Current
49035-703	Budesonide	Budesonide	Walmart	ANDA	Current
60505-0839	Budesonide Nasal	Budesonide	Apotex Corp.	ANDA	Current
60505-0839	Budesonide Nasal	Budesonide	Apotex Corp.	ANDA	Current
60505-0839	Budesonide Nasal	Budesonide	Apotex Corp.	ANDA	Current
60505-6129	Budesonide	Budesonide	Apotex Corp.	ANDA	Current
60505-6129	Budesonide	Budesonide	Apotex Corp.	ANDA	Current
60505-6129	Budesonide	Budesonide	Apotex Corp.	ANDA	Current
60505-6194	Budesonide	Budesonide	Apotex Corp.	ANDA	Current
60505-6194	Budesonide	Budesonide	Apotex Corp.	ANDA	Current
60505-6194	Budesonide	Budesonide	Apotex Corp.	ANDA	Current
60505-6194	Budesonide	Budesonide	Apotex Corp.	ANDA	Current
69842-001	Budesonide	Budesonide	CVS Pharmacy	ANDA	Current
69842-001	Budesonide	Budesonide	CVS Pharmacy	ANDA	Current
69842-001	Budesonide	Budesonide	CVS Pharmacy	ANDA	Current