Application 208820

Type: ANDA
Sponsor: PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRAZIQUANTEL	PRAZIQUANTEL	TABLET;ORAL	600MG	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
A208820-001	PRAZIQUANTEL	PRAZIQUANTEL	600MG	TABLET / ORAL		RS	2017-11-27

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL		RS	2017-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL		RS	2017-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL		RS	2017-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL		RS	2017-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL		RS	2017-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL		RS	2017-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL		RS	2017-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB	RS	2017-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL		RS	2017-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL		RS	2017-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB	RS	2017-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB	RS	2017-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208820-001	PRAZIQUANTEL	600MG	TABLET / ORAL	AB		2017-11-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208820-001	AB	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208820-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208820-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208820-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208820-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208820-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208820-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208820-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208820-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208820-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208820-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208820-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208820-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208820-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208820-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208820-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208820-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208820-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208820-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208820-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208820-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208820-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208820-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208820-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208820-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208820-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208820-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208820-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208820-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208820-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208820-001	AB	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRAZIQUANTEL	PRAZIQUANTEL	Endo USA, Inc.	16f2b9c4-a260-4a31-bd52-e5945913246c	2024-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208820 application number: ANDA208820 ndc (product): 49884-231

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
49884-231	PRAZIQUANTEL	PRAZIQUANTEL	Par Pharmaceutical, Inc.	ANDA	Current
49884-231	PRAZIQUANTEL	PRAZIQUANTEL	Par Pharmaceutical, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50559	ORIG	2017-12-01