Application 075282

Type: ANDA
Sponsor: SANDOZ INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CROMOLYN SODIUM	CROMOLYN SODIUM	SOLUTION/DROPS;OPHTHALMIC	4%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075282-001	CROMOLYN SODIUM	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16

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 · 42 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
2026-08-18 06:07:40	2026-07	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075282-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075282-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075282-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075282-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075282-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075282-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075282-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075282-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075282-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075282-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075282-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075282-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075282-001	AT	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A075282-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075282-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075282-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075282-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075282-001	AT	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cromolyn Sodium	CROMOLYN SODIUM	Preferred Pharmaceuticals Inc.	18892411-465f-4d8d-9550-7dafa6c6a0a3	2026-04-01	Adverse reactions	Exact identifier application applno (ANDA): 075282 application number: ANDA075282
Cromolyn Sodium	CROMOLYN SODIUM	Sandoz Inc	b32851c3-cd97-4be4-a09c-1deab1d6966b	2025-02-20	Adverse reactions	Exact identifier application applno (ANDA): 075282 application number: ANDA075282 ndc (product): 61314-237
Cromolyn Sodium	CROMOLYN SODIUM	A-S Medication Solutions	0d30fb0a-e343-426d-8203-5816bd4cec2f	2024-11-07	Adverse reactions	Exact identifier application applno (ANDA): 075282 application number: ANDA075282 ndc (product): 50090-1202
Cromolyn Sodium	CROMOLYN SODIUM	Proficient Rx LP	34ef00e8-0c01-4225-9a40-822ab245752a	2019-10-01	Adverse reactions	Exact identifier application applno (ANDA): 075282 application number: ANDA075282 ndc (product): 71205-230

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-1202	Cromolyn Sodium	Cromolyn Sodium	A-S Medication Solutions	ANDA	Current
50090-1202	Cromolyn Sodium	Cromolyn Sodium	A-S Medication Solutions	ANDA	Current
50090-1202	Cromolyn Sodium	Cromolyn Sodium	A-S Medication Solutions	ANDA	Current
50090-1202	Cromolyn Sodium	Cromolyn Sodium	A-S Medication Solutions	ANDA	Current
53002-0140	Cromolyn Sodium	Cromolyn Sodium	RPK Pharmaceuticals, Inc.	ANDA	Current
61314-237	Cromolyn Sodium	Cromolyn Sodium	Sandoz Inc	ANDA	Current
61314-237	Cromolyn Sodium	Cromolyn Sodium	Sandoz Inc	ANDA	Current
61314-237	Cromolyn Sodium	Cromolyn Sodium	Sandoz Inc	ANDA	Current
71205-230	Cromolyn Sodium	Cromolyn Sodium	Proficient Rx LP	ANDA	Current
71205-230	Cromolyn Sodium	Cromolyn Sodium	Proficient Rx LP	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8597	ORIG	1999-06-16