Application 040327

Type: ANDA
Sponsor: SANDOZ

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	Yes

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
A040327-001	ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A040327-001	AB

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	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040327-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040327-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040327-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040327-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040327-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040327-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040327-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040327-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040327-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040327-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040327-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040327-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040327-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040327-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040327-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040327-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040327-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040327-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040327-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040327-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040327-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040327-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040327-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040327-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040327-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040327-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040327-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040327-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040327-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040327-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040327-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040327-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040327-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040327-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040327-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040327-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040327-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040327-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040327-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040327-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Orphenadrine Citrate	ORPHENADRINE CITRATE	RedPharm Drug	1cff761d-e594-a9e6-e063-6394a90a1fd5	2024-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040327 application number: ANDA040327
Orphenadrine Citrate	ORPHENADRINE CITRATE	Sandoz Inc	239018ff-cec6-46de-ae9d-26c9ec034a32	2024-03-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040327 application number: ANDA040327 ndc (product): 0185-0022
Orphenadrine Citrate	ORPHENADRINE CITRATE	Proficient Rx LP	37e6a157-5d0d-4887-9a26-ed5521fb08e6	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040327 application number: ANDA040327 ndc (product): 63187-632

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-0022	Orphenadrine Citrate	Orphenadrine Citrate	Eon Labs, Inc.	ANDA	Current
0185-0022	Orphenadrine Citrate	Orphenadrine Citrate	Eon Labs, Inc.	ANDA	Current
0185-0022	Orphenadrine Citrate	Orphenadrine Citrate	Eon Labs, Inc.	ANDA	Current
45865-363	Orphenadrine Citrate	Orphenadrine Citrate	Medsource Pharmaceuticals	ANDA	Current
63187-632	Orphenadrine Citrate	Orphenadrine Citrate	Proficient Rx LP	ANDA	Current
63187-632	Orphenadrine Citrate	Orphenadrine Citrate	Proficient Rx LP	ANDA	Current
68151-1463	Orphenadrine Citrate	Orphenadrine Citrate	Carilion Materials Management	ANDA	Current
68788-9306	Orphenadrine Citrate	Orphenadrine Citrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
71335-0117	Orphenadrine Citrate	Orphenadrine Citrate	Bryant Ranch Prepack	ANDA	Current
71335-0117	Orphenadrine Citrate	Orphenadrine Citrate	Bryant Ranch Prepack	ANDA	Current
71335-0117	Orphenadrine Citrate	Orphenadrine Citrate	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
29929	ORIG	2000-02-15