Application 040368

Type: ANDA
Sponsor: IMPAX PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	TABLET, EXTENDED RELEASE;ORAL	100MG	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
A040368-001	ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL			2000-06-23

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-06-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-06-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-06-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-06-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-06-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-06-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040368-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2000-06-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040368-001	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A040368-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040368-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040368-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040368-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040368-001	AB	1	`ea99ee380514…`

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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Orphenadrine Citrate	ORPHENADRINE CITRATE	St. Mary's Medical Park Pharmacy	59000b66-166e-75d2-e053-2a91aa0af3c0	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Orphenadrine Citrate generic name: ORPHENADRINE CITRATE
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	REMEDYREPACK INC.	7905e80f-b60b-48e8-8e63-a3e50211bfe4	2026-04-28	Warnings, Adverse reactions	Name fallback brand name: ORPHENADRINE CITRATE generic name: ORPHENADRINE CITRATE
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	Bryant Ranch Prepack	1b4e379e-8051-421f-a0f4-ad9e6fb9476a	2026-02-26	Warnings, Adverse reactions	Name fallback brand name: ORPHENADRINE CITRATE generic name: ORPHENADRINE CITRATE
Orphenadrine Citrate	ORPHENADRINE CITRATE	A-S Medication Solutions	80ef7fb4-7c50-4d25-915e-f9d4a2ccd199	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: Orphenadrine Citrate generic name: ORPHENADRINE CITRATE
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	PD-Rx Pharmaceuticals, Inc.	87d78229-f022-4b42-a03c-4e6a985c714f	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: ORPHENADRINE CITRATE generic name: ORPHENADRINE CITRATE
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	Northwind Health Company, LLC	106be130-b4f8-5ca1-e063-6294a90a1590	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: ORPHENADRINE CITRATE generic name: ORPHENADRINE CITRATE
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	Lupin Pharmaceuticals, Inc.	7b76c8a7-dd0c-481c-8299-26dfd38ce066	2025-09-10	Warnings, Adverse reactions	Name fallback brand name: ORPHENADRINE CITRATE generic name: ORPHENADRINE CITRATE
Orphenadrine Citrate	ORPHENADRINE CITRATE	Preferred Pharmaceuticals, Inc.	8ca9438d-320f-4499-aee7-6b8ca7cccc65	2025-09-04	Warnings, Adverse reactions	Name fallback brand name: Orphenadrine Citrate generic name: ORPHENADRINE CITRATE
Orphenadrine Citrate ER	ORPHENADRINE CITRATE	Advanced Rx Pharmacy of Tennessee, LLC	b5a6846a-ebb3-1fdd-e053-2a95a90a4130	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: ORPHENADRINE CITRATE
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	Advanced Rx Pharmacy of Tennessee, LLC	fc63d413-39bd-409d-e053-6294a90a1463	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: ORPHENADRINE CITRATE generic name: ORPHENADRINE CITRATE
Orphenadrine Citrate	ORPHENADRINE CITRATE	Lake Erie Medical DBA Quality Care Products LLC	233915f1-7d58-4b4c-a2bb-e73179d61d07	2024-12-16	Warnings, Adverse reactions	Name fallback brand name: Orphenadrine Citrate generic name: ORPHENADRINE CITRATE
Orphenadrine Citrate	ORPHENADRINE CITRATE	Bryant Ranch Prepack	8408d24e-3948-548d-bb12-b1edf0c05e12	2024-08-27	Warnings, Adverse reactions	Name fallback brand name: Orphenadrine Citrate generic name: ORPHENADRINE CITRATE
Orphenadrine Citrate	ORPHENADRINE CITRATE	NuCare Pharmaceuticals, Inc.	3eb1b1cc-ed7a-6f0f-e054-00144ff88e88	2024-08-13	Warnings, Adverse reactions	Name fallback brand name: Orphenadrine Citrate generic name: ORPHENADRINE CITRATE
Orphenadrine citrate	ORPHENADRINE CITRATE	Hikma Pharmaceuticals USA Inc.	ed406e8a-ec00-4711-ae2b-3c5af4f15438	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: Orphenadrine citrate generic name: ORPHENADRINE CITRATE
Orphenadrine Citrate	ORPHENADRINE CITRATE	RedPharm Drug	1cff761d-e594-a9e6-e063-6394a90a1fd5	2024-07-11	Warnings, Adverse reactions	Name fallback brand name: Orphenadrine Citrate generic name: ORPHENADRINE CITRATE
Orphenadrine Citrate	ORPHENADRINE CITRATE	Sandoz Inc	239018ff-cec6-46de-ae9d-26c9ec034a32	2024-03-22	Warnings, Adverse reactions	Name fallback brand name: Orphenadrine Citrate generic name: ORPHENADRINE CITRATE
Orphenadrine Citrate	ORPHENADRINE CITRATE	Proficient Rx LP	cf620257-7497-44c1-9853-87f96d262fbd	2023-12-01	Warnings, Adverse reactions	Name fallback brand name: Orphenadrine Citrate generic name: ORPHENADRINE CITRATE
Orphenadrine Citrate	ORPHENADRINE CITRATE	Sagent Pharmaceuticals	c8d8596a-b81f-4b83-a2f3-a55922ca4a82	2023-11-14	Warnings, Adverse reactions	Name fallback brand name: Orphenadrine Citrate generic name: ORPHENADRINE CITRATE
Orphenadrine Citrate	ORPHENADRINE CITRATE	Proficient Rx LP	37e6a157-5d0d-4887-9a26-ed5521fb08e6	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Orphenadrine Citrate generic name: ORPHENADRINE CITRATE
Orphenadrine Citrate	ORPHENADRINE CITRATE	Actavis Pharma, Inc.	aec8ad3a-f717-4e74-b7b9-19debdaad79a	2016-07-20	Warnings, Adverse reactions	Name fallback brand name: Orphenadrine Citrate generic name: ORPHENADRINE CITRATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-2011	Orphenadrine Citrate	ORPHENADRINE CITRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-2011	Orphenadrine Citrate	ORPHENADRINE CITRATE	Impax Generics	ANDA	Current
0115-2011	Orphenadrine Citrate	ORPHENADRINE CITRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
50090-3150	Orphenadrine Citrate	ORPHENADRINE CITRATE	A-S Medication Solutions	ANDA	Current
50090-3150	Orphenadrine Citrate	ORPHENADRINE CITRATE	A-S Medication Solutions	ANDA	Current
52959-527	Orphenadrine Citrate	ORPHENADRINE CITRATE	H.J. Harkins Company, Inc.	ANDA	Current
68084-820	Orphenadrine Citrate	ORPHENADRINE CITRATE	American Health Packaging	ANDA	Current
68084-820	Orphenadrine Citrate	ORPHENADRINE CITRATE	American Health Packaging	ANDA	Current
68084-820	Orphenadrine Citrate	ORPHENADRINE CITRATE	American Health Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
7639	ORIG	2000-06-23