Application 075271

Type: ANDA
Sponsor: TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CROMOLYN SODIUM	CROMOLYN SODIUM	SOLUTION;INHALATION	10MG/ML	No	Yes

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

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
A075271-001	CROMOLYN SODIUM	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075271-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075271-001	AN	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075271-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075271-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075271-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075271-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075271-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075271-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075271-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075271-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075271-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075271-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075271-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075271-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075271-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075271-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075271-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075271-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075271-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075271-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075271-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075271-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075271-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075271-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075271-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075271-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075271-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075271-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075271-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075271-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075271-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075271-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075271-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075271-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075271-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075271-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075271-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075271-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075271-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075271-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075271-001	AN	1	`f41ea6bd6efb…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cromolyn Sodium	CROMOLYN SODIUM	Teva Pharmaceuticals USA, Inc.	8fe37a7a-edd6-4733-bb7e-e01c1906aeba	2023-12-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075271 application number: ANDA075271 ndc (product): 0172-6406

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0172-6406	Cromolyn Sodium	Cromolyn Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-6406	Cromolyn Sodium	Cromolyn Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-6406	Cromolyn Sodium	Cromolyn Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42969	ORIG	2001-12-26
18401	ORIG	2000-02-04
8591	ORIG	2000-01-18