Application 075141

Type: ANDA
Sponsor: GALT PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ORPHENGESIC	ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE	TABLET;ORAL	385MG;30MG;25MG	No	No
002	ORPHENGESIC FORTE	ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE	TABLET;ORAL	770MG;60MG;50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075141-001	ORPHENGESIC	ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE	385MG;30MG;25MG	TABLET / ORAL			1998-05-29
A075141-002	ORPHENGESIC FORTE	ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29

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 3 · 82 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	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL	AB		1998-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`782e0a99824c…`

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	A075141-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075141-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075141-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075141-002	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Norgesic	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE	Galt Pharmaceuticals, LLC	be2761bc-e537-4039-846a-2ffa3d8b2afc	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075141 application number: ANDA075141 ndc (product): 61825-305
Norgesic Forte	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE	Poly Pharmaceuticals, Inc.	85a3b808-b476-f2f0-e053-2a91aa0af21f	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075141 application number: ANDA075141 ndc (product): 50991-999
Orphenadrine Citrate, Aspirin and Caffeine	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE	Atland Pharmaceuticals, LLC	7776aae6-3cbd-4aed-9aac-4bed80339e27	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075141 application number: ANDA075141
ORPHENGESIC FORTE	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE	Galt Pharmaceuticals, LLC	5bc485db-9d96-4291-aaa3-2a96ebf3098a	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075141 application number: ANDA075141 ndc (product): 61825-302
Orphenadrine Citrate, Aspirin and Caffeine	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE	Atland Pharmaceuticals, LLC	61ca2af1-081c-411c-90ce-ec6d9e3157b2	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075141 application number: ANDA075141 ndc (product): 71993-304

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50991-999	Norgesic Forte	Orphenadrine Citrate, Aspirin and Caffeine	Poly Pharmaceuticals, Inc.	ANDA	Current
50991-999	Norgesic Forte	Orphenadrine Citrate, Aspirin and Caffeine	Poly Pharmaceuticals, Inc.	ANDA	Current
50991-999	Norgesic Forte	Orphenadrine Citrate, Aspirin and Caffeine	Poly Pharmaceuticals, Inc.	ANDA	Current
50991-999	Norgesic Forte	Orphenadrine Citrate, Aspirin and Caffeine	Poly Pharmaceuticals, Inc.	ANDA	Current
61825-302	ORPHENGESIC FORTE	Orphenadrine Citrate, Aspirin and Caffeine	Galt Pharmaceuticals, LLC	ANDA	Current
61825-302	ORPHENGESIC FORTE	Orphenadrine Citrate, Aspirin and Caffeine	Galt Pharmaceuticals, LLC	ANDA	Current
61825-302	ORPHENGESIC FORTE	Orphenadrine Citrate, Aspirin and Caffeine	Galt Pharmaceuticals, LLC	ANDA	Current
61825-305	Norgesic	Orphenadrine Citrate, Aspirin and Caffeine	Galt Pharmaceuticals, LLC	ANDA	Current
61825-999	Orphengesic Forte	Orphenadrine Citrate, Aspirin and Caffeine	Galt Pharmaceuticals, LLC	ANDA	Current
61825-999	Orphengesic Forte	Orphenadrine Citrate, Aspirin and Caffeine	Galt Pharmaceuticals, LLC	ANDA	Current
71993-304	Orphenadrine Citrate, Aspirin and Caffeine	Orphenadrine Citrate, Aspirin and Caffeine	Atland Pharmaceuticals, LLC	ANDA	Current
71993-304	Orphenadrine Citrate, Aspirin and Caffeine	Orphenadrine Citrate, Aspirin and Caffeine	Atland Pharmaceuticals, LLC	ANDA	Current
71993-999	Orphenadrine Citrate, Aspirin and Caffeine	Orphenadrine Citrate, Aspirin and Caffeine	Atland Pharmaceuticals, LLC	ANDA	Current
71993-999	Orphenadrine Citrate, Aspirin and Caffeine	Orphenadrine Citrate, Aspirin and Caffeine	Atland Pharmaceuticals, LLC	ANDA	Current
74157-999	Orphenadrine Citrate, Aspirin and Caffeine	orphenadrine citrate, aspirin and caffeine	INA Pharmaceutics, Inc	ANDA	Current
74157-999	Orphenadrine Citrate, Aspirin and Caffeine	orphenadrine citrate, aspirin and caffeine	INA Pharmaceutics, Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22431	ORIG	1998-05-29