Application 090145

Type: ANDA
Sponsor: NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE	FOR SOLUTION;ORAL	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	No	No

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
A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA		2012-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090145-001	AA

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 2 of 2 · 43 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
2022-09-29 23:25 UTC	2022-09	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090145-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090145-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090145-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090145-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090145-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090145-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090145-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090145-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090145-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090145-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090145-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090145-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090145-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090145-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090145-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090145-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090145-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090145-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090145-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A090145-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090145-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090145-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090145-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090145-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090145-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090145-001	AA	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090145-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090145-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090145-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090145-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090145-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090145-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090145-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090145-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090145-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090145-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090145-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090145-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090145-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090145-001	AA	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A090145-001	PC	2021-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090145-001	PC	2021-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090145-001	PC	2021-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090145-001	PC	2021-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090145-001	PC	2021-02-27	`c0c555d07b60…`

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
PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	Teva Pharmaceuticals USA, Inc.	475a06c6-f295-406c-a110-f1497cf51566	2022-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090145 application number: ANDA090145 ndc (product): 0093-3560

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-3560	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3560	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	Teva Pharmaceuticals USA, Inc.	ANDA	Current