Application 075437

Type: ANDA
Sponsor: FERA PHARMS LLC

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	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
A075437-001	CROMOLYN SODIUM	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN		2000-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075437-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075437-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075437-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075437-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075437-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075437-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075437-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075437-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075437-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075437-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075437-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075437-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075437-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075437-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075437-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075437-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075437-001	AN	1	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075437-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075437-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075437-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075437-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075437-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075437-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075437-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075437-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075437-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075437-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075437-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075437-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075437-001	AN	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075437-001	AN	1	`a50c72e98297…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NasalCrom	CROMOLYN SODIUM	Prestige Brands Holdings, Inc.	b34d36ca-4df4-458c-af0f-c0d0c9a025d9	2026-06-03	Warnings	Name fallback generic name: CROMOLYN SODIUM
Cromolyn Sodium	CROMOLYN SODIUM	Preferred Pharmaceuticals Inc.	18892411-465f-4d8d-9550-7dafa6c6a0a3	2026-04-01	Adverse reactions	Name fallback brand name: Cromolyn Sodium generic name: CROMOLYN SODIUM
CROMOLYN SODIUM	CROMOLYN SODIUM	Omnivium Pharmaceuticals LLC	a742664b-265e-49f9-9744-d04e1fb620ae	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: CROMOLYN SODIUM generic name: CROMOLYN SODIUM
Cromolyn Sodium	CROMOLYN SODIUM	Sandoz Inc	b32851c3-cd97-4be4-a09c-1deab1d6966b	2025-02-20	Adverse reactions	Name fallback brand name: Cromolyn Sodium generic name: CROMOLYN SODIUM
Cromolyn Sodium	CROMOLYN SODIUM	A-S Medication Solutions	0d30fb0a-e343-426d-8203-5816bd4cec2f	2024-11-07	Adverse reactions	Name fallback brand name: Cromolyn Sodium generic name: CROMOLYN SODIUM
CROMOLYN SODIUM	CROMOLYN SODIUM	Micro Labs Limited	93f80edb-3b38-423e-8cd6-5b5cb4393ec2	2024-09-26	Warnings, Adverse reactions	Name fallback brand name: CROMOLYN SODIUM generic name: CROMOLYN SODIUM
Gastrocrom	CROMOLYN SODIUM	Viatris Specialty LLC	00623958-a8fe-47d1-a0d2-0aa4e2f7966e	2024-06-26	Warnings, Adverse reactions	Name fallback generic name: CROMOLYN SODIUM
Cromolyn Sodium	CROMOLYN SODIUM	Teva Pharmaceuticals USA, Inc.	8fe37a7a-edd6-4733-bb7e-e01c1906aeba	2023-12-14	Warnings, Adverse reactions	Name fallback brand name: Cromolyn Sodium generic name: CROMOLYN SODIUM
CROMOLYN SODIUM	CROMOLYN SODIUM	Rising Pharma Holdings, Inc.	61c9cb85-129e-4490-b5f7-357307fcecbf	2021-08-01	Warnings, Adverse reactions	Name fallback brand name: CROMOLYN SODIUM generic name: CROMOLYN SODIUM
Cromolyn Sodium	CROMOLYN SODIUM	Bausch & Lomb Incorporated	379f4b59-6866-4b5c-9b1b-d8a35b741461	2021-06-01	Warnings	Name fallback brand name: Cromolyn Sodium generic name: CROMOLYN SODIUM
Cromolyn Sodium	CROMOLYN SODIUM	Proficient Rx LP	34ef00e8-0c01-4225-9a40-822ab245752a	2019-10-01	Adverse reactions	Name fallback brand name: Cromolyn Sodium generic name: CROMOLYN SODIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
48102-033	Cromolyn Sodium Inhalation	cromolyn sodium	Fera Pharmaceuticals, LLC	ANDA	Current
60940-032	Cromolyn Sodium Inhalation Solution	Cromolyn Sodium	Holopack Verpackungstechnik GmbH	ANDA	Current