Application 201384

Type: ANDA
Sponsor: SUN PHARM

Related Records

Company: SUN PHARM

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	100MG	No	No
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
35356-790	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-790	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-790	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
45865-876	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	medsource pharmaceuticals	ANDA	Current
45865-900	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	medsource pharmaceuticals	ANDA	Current
47335-859	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-859	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-859	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-859	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-859	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-860	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-860	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-860	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-860	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-860	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-861	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-861	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-861	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-861	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-861	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
50090-2215	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
50090-6033	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
55700-016	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-016	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-016	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-029	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-029	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-029	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Quality Care Products LLC	ANDA	Current
61919-892	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DirectRX	ANDA	Current
61919-892	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DirectRX	ANDA	Current
61919-892	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DirectRX	ANDA	Current
61919-892	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DirectRX	ANDA	Current
61919-893	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-893	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-893	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-893	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-893	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-893	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	ANDA	Current
63187-597	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
63187-597	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
63187-597	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
63629-8324	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
63629-8324	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
63629-8324	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
68071-2648	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2732	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7373	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals	ANDA	Current
68788-7762	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7762	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7762	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7763	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7763	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7763	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-8921	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9232	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals	ANDA	Current
68788-9237	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals	ANDA	Current
70518-3386	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-3397	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-3418	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
71205-656	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
71205-708	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
71335-1675	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-1675	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-1675	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-1676	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-1676	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-1676	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
76420-244	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc.	ANDA	Current
76420-245	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc.	ANDA	Current
76420-246	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc.	ANDA	Current
76519-1132	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	H. J. Harkins Company Inc.	ANDA	Current
76519-1142	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	H.J. Harkins Company, Inc.	ANDA	Current
80425-0141	Ultram	Tramadol 100mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0141	Ultram	Tramadol 100mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0141	Tramadol HCL	Tramadol HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0141	Tramadol HCL	Tramadol HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0141	Tramadol HCL	Tramadol HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current

Documents

Document	Submission type	Date
76067	ORIG	2023-11-02