Application 076652

Type: ANDA
Sponsor: LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLYCOLAX	POLYETHYLENE GLYCOL 3350	FOR SOLUTION;ORAL	17GM/SCOOPFUL	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
A076652-001	GLYCOLAX	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL			2004-07-02

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076652-001	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2004-07-02	`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 5 of 5 · 93 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
laxative	POLYETHYLENE GLYCOL 3350	Rite Aid Corporation	3ebe9191-8e0a-41cf-b759-82ecce4f50e4	2023-02-10	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
dg health clearlax	POLYETHYLENE GLYCOL 3350	Dolgencorp, LLC	94280ce4-b2cf-451d-a660-b26ab1a2d3f0	2023-02-06	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
clearlax	POLYETHYLENE GLYCOL 3350	H E B	0b4b752d-045d-4ff0-8e50-5607d1a841a7	2023-01-26	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
Good Sense Clear Lax	POLYETHYLENE GLYCOL 3350	L. Perrigo Company	435db89c-1e32-4da5-b7d0-15e407162715	2023-01-24	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
basic care clearlax	POLYETHYLENE GLYCOL 3350	Amazon.com Services LLC	21897170-0d5e-4326-bebf-10258e0aca82	2022-12-08	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	Geri-Care Pharmaceutical Corp	f4c7eb80-d8d5-406d-90d0-9d17914d71f2	2022-11-24	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Gericare Pharmaceuticals	5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd	2022-10-28	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
Equate ClearLAX	POLYETHYLENE GLYCOL 3350	WALMART INC.	c5c13378-3c08-415f-8ab4-8a18d6300ca8	2022-09-08	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
injoy constipation relief	POLYETHYLENE GLYCOL 3350	L. Perrigo Company	b2414517-04bf-4f29-951e-b867855078c3	2022-08-19	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
Good Sense Clear Lax	POLYETHYLENE GLYCOL 3350	Proficient Rx LP	0858a914-4812-4e4d-82f8-ecf93d43ef3b	2022-07-01	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
GAVILAX	POLYETHYLENE GLYCOL 3350	Proficient Rx LP	199d6173-3fad-49e4-88fe-bde7223ed4c3	2022-06-01	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
signature care clearlax	POLYETHYLENE GLYCOL 3350	Safeway	91d2e780-2aae-411c-b7b3-820302f0f63e	2021-05-13	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 3350 NF	POLYETHYLENE GLYCOL 3350	SUNRISE PHARMACEUTICAL, INC	ce5197a1-2677-4ffb-aef2-9221b28ebd23	2020-01-22	Warnings	Name fallback generic name: POLYETHYLENE GLYCOL 3350

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62175-442	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	Lannett Company, Inc..	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43095	ORIG	2007-07-20