Application 075141

Type: ANDA
Sponsor: GALT PHARMS

Related Records

Company: GALT PHARMS

Application Products

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

NDC Listings For This Application

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	Title	Submission type	Submission no.	Date
22431	0	ORIG	1	1998-05-29