Application 212789

Type: ANDA
Sponsor: HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE	FOR SOLUTION;ORAL	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	No	Yes

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
A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL		RS	2022-07-18

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`a50c72e98297…`

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
31722-874	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	Camber Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71962	ORIG	2022-08-30