Application 202104

Type: ANDA
Sponsor: UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	No	No
002	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	No	No
003	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	No	No
004	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	50MG	No	No
005	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	60MG	No	No
006	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	80MG	No	No
007	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	100MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0832-0225	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0225	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0225	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0226	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0226	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0226	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0227	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0227	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0227	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0228	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0228	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0228	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0229	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0229	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0229	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0230	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0230	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0230	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0233	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0233	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0233	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
55700-349	Morphine Sulfate	Morphine Sulfate	Quality Care Products LLC	ANDA	Current
55700-349	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-349	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-349	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-349	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-349	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-350	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-350	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-552	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-552	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24099	ORIG	2015-06-30