Application 202217

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 CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	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
A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL			2014-08-20

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	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202217-001	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM	FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL	2014-08-20	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GaviLyte-H and Bisacodyl	POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET	Lupin Pharmaceuticals, Inc.	78fe1c29-e22a-4615-a2f9-a61cd4eb38a3	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202217 application number: ANDA202217 ndc (product): 43386-071

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
43386-071	GaviLyte-H and Bisacodyl	Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride and Bisacodyl Delayed-release Tablet	GAVIS Pharmaceuticals, LLC	ANDA	Current
43386-071	GaviLyte-H and Bisacodyl	Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride and Bisacodyl Delayed-release Tablet	Lupin Pharmaceuticals, Inc.	ANDA	Current