Application 200503

Type: ANDA
Sponsor: LUPIN LTD

Related Records

Company: LUPIN LTD

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	100MG	No	Yes
002	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	200MG	No	No
003	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	300MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45865-969	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	medsource pharmaceuticals	ANDA	Current
45865-976	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	medsource pharmaceuticals	ANDA	Current
50090-5106	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
50090-5107	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
50436-0698	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Unit Dose Services	ANDA	Current
61919-818	TRAMADOL HCL	TRAMADOL HCL	DIRECT RX	ANDA	Current
61919-818	TRAMADOL HCL	TRAMADOL HCL	DIRECT RX	ANDA	Current
61919-818	TRAMADOL HCL	TRAMADOL HCL	DIRECT RX	ANDA	Current
61919-818	TRAMADOL HCL	TRAMADOL HCL	DIRECT RX	ANDA	Current
61919-818	TRAMADOL HCL	TRAMADOL HCL	DIRECT RX	ANDA	Current
63629-8319	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
63629-8319	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
63629-8323	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
63629-8323	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
68071-1671	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1671	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2329	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2410	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5078	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5078	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5261	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5261	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68180-697	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-697	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-697	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-697	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-697	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-697	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-697	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-698	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-698	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-698	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-698	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-698	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-698	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-698	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-699	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-699	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-699	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-699	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-699	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-699	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-699	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68788-7601	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7601	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68788-7601	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7601	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7609	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0886	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-0886	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-0886	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-0886	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-0886	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-0886	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-0886	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-0942	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-0942	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-0942	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-0942	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-0942	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-0942	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2795	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2795	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2795	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2795	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
71205-463	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
71205-463	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
71205-468	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
71205-468	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
71205-569	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
71205-569	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
72189-154	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	ANDA	Current
80425-0108	Ultram	Tramadol HCl 100mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0108	Tramadol HCL	Tramadol HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0108	Tramadol HCL	Tramadol HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0108	Tramadol HCL	Tramadol HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0136	Conzip	Tramadol HCl 200mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0136	Tramadol HCL	Tramadol HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0136	Tramadol HCL	Tramadol HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0136	Tramadol HCL	Tramadol HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current

Documents

Document	Submission type	Date
76104	ORIG	2023-11-02