Application 209008

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PSEUDOEPHEDRINE HYDROCHLORIDE	PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	120MG	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
A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL			2017-06-09

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	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209008-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2017-06-09	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pseudoephedrine HCl	PSEUDOEPHEDRINE HCL	Better Living Brands LLC	f9d5a22a-3964-08b8-e053-6294a90ab220	2024-07-24	Warnings	Exact identifier application applno (ANDA): 209008 application number: ANDA209008
Pseudoephedrine HCl	PSEUDOEPHEDRINE HCL	Aurohealth LLC	1056d9da-8a3f-4b7a-878e-7f8d45d298cd	2022-11-03	Warnings	Exact identifier application applno (ANDA): 209008 application number: ANDA209008 ndc (product): 58602-804

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
58602-804	Pseudoephedrine HCl	Pseudoephedrine HCl	Aurohealth LLC	ANDA	Current
58602-804	Pseudoephedrine HCl	Pseudoephedrine HCl	Aurohealth LLC	ANDA	Current
58602-804	Pseudoephedrine HCl	Pseudoephedrine HCl	Aurohealth LLC	ANDA	Current