FDA Approval Activities for this Drug…

Avinza (morphine sulfate extended-release) Capsules, 30, 60, 90, and 120 mg, Elan Drug Delivery, NDA 21-260 Duramorph (morphine sulfate injection) and Infumorph, (preservative-free morphine sulfate sterile solution) Elkins-Sinn NDA 18-565/S-010 Morphine Sulfate Extended-release Tablets, 100 & 200 mg, Mallinckrodt ANDA 76-438 7/3/03 Morphine Sulfate Extended-release Tablets, 15, 30 & 60 mg, Mallinckrodt ANDA 76-412 7/31/03 Morphine Sulfate Extended-release Tablets, 100 mg, Watson, ANDA 75-656 1/30/01 3/5/01 Morphine Sulfate Extended-release Tablets, 15 mg, ESI Lederle ANDA 75-407 1/28/00 2/4/00 Morphine Sulfate Extended-release Tablets, 15 mg, 30 mg, 60 mg, only Generics L.P. ANDA 74-862 7/7/98 7/10 3/30/99 Morphine Sulfate Extended-release Tablets, 15 mg, 30 mg, and 60 mg, Endo ANDA 75-295 10/28/98 1/12/99 Morphine Sulfate Extended-release Tablets, 100 mg and 200 mg mg, Endo ANDA 75-295 S007 9/15/00 Morphine Sulfate Extended-release Tablets, 100 mg and 200 mg, RX only Generics L.P. ANDA 74-769 MS Contin (morphine sulfate controlled-release) Tablets, 10, 30, 60, 100, and 200 mg, The Purdue Frederick Company NDA 19-516/S-021 8/6/03 8/14/03 MS Contin (morphine sulfate controlled-release) Tablets, 15, 30, 60, 100, and 200 mg, The Purdue Frederick Company NDA 19-516/S-019 Oramorph (morphine sulfate) Sustained Release Tablets Roxane, NDA 19-977/S-004, S-007 MORPHINE SULFATE Capsule, Extended Release; 100MG KADIAN Faulding 020616 MORPHINE SULFATE Capsule, Extended Release; 20MG KADIAN Faulding 020616 BX MORPHINE SULFATE Capsule, Extended Release; 30MG KADIAN Faulding 020616 MORPHINE SULFATE Capsule, Extended Release; 50MG KADIAN Faulding 020616 BX MORPHINE SULFATE Capsule, Extended Release; 60MG KADIAN Faulding 021260 MORPHINE SULFATE Capsule, Extended Release; 120MG AVINZA LIGAND 021260 BX MORPHINE SULFATE Capsule, Extended Release; 30MG AVINZA LIGAND 021260 BX MORPHINE SULFATE Capsule, Extended Release; 60MG AVINZA LIGAND 021260 MORPHINE SULFATE Capsule, Extended Release; 90MG AVINZA LIGAND 019917 MORPHINE SULFATE Injection 0.5MG/ML MORPHINE SULFATE Abbott 073509 MORPHINE SULFATE Injection 0.5MG/ML MORPHINE SULFATE Abbott 071849 MORPHINE SULFATE Injection 0.5MG/ML MORPHINE SULFATE Abbott 071850 MORPHINE SULFATE Injection 1MG/ML MORPHINE SULFATE Abbott 073510 MORPHINE SULFATE Injection 1MG/ML MORPHINE SULFATE Abbott 019916 MORPHINE SULFATE Injection 1MG/ML MORPHINE SULFATE Abbott 071050 MORPHINE SULFATE Injection 0.5MG/ML ASTRAMORPH PF ASTRAZENECA 071051 MORPHINE SULFATE Injection 0.5MG/ML ASTRAMORPH PF ASTRAZENECA 071052 MORPHINE SULFATE Injection 1MG/ML ASTRAMORPH PF ASTRAZENECA 071053 MORPHINE SULFATE Injection 1MG/ML ASTRAMORPH PF ASTRAZENECA 018565 MORPHINE SULFATE Injection 0.5MG/ML DURAMORPH PF Baxter 018565 MORPHINE SULFATE Injection 10MG/ML INFUMORPH Baxter 018565 MORPHINE SULFATE Injection 1MG/ML DURAMORPH PF Baxter 018565 MORPHINE SULFATE Injection 25MG/ML INFUMORPH Baxter 020631 MORPHINE SULFATE Injection 1MG/ML MORPHINE SULFATE Mallinckrodt 020631 MORPHINE SULFATE Injection 2MG/ML MORPHINE SULFATE Mallinckrodt 019999 MORPHINE SULFATE Injection 15MG/ML MORPHINE SULFATE MERIDIAN MEDCL TECHN 073373 MORPHINE SULFATE Injection 0.5MG/ML MORPHINE SULFATE STERIS 073375 MORPHINE SULFATE Injection 0.5MG/ML MORPHINE SULFATE STERIS 073376 MORPHINE SULFATE Injection 1MG/ML MORPHINE SULFATE STERIS 073374 MORPHINE SULFATE Injection 1MG/ML MORPHINE SULFATE STERIS 074769 MORPHINE SULFATE Tablet, Extended Release; 100MG MORPHINE SULFATE GENERICS 074862 MORPHINE SULFATE Tablet, Extended Release; 15MG MORPHINE SULFATE GENERICS 074769 MORPHINE SULFATE Tablet, Extended Release; 200MG MORPHINE SULFATE GENERICS 074862 MORPHINE SULFATE Tablet, Extended Release; 30MG MORPHINE SULFATE GENERICS 074862 MORPHINE SULFATE Tablet, Extended Release; 60MG MORPHINE SULFATE GENERICS 019977 BC MORPHINE SULFATE Tablet, Extended Release; 100MG ORAMORPH SR ELAN 019977 BC MORPHINE SULFATE Tablet, Extended Release; 15MG ORAMORPH SR ELAN 019977 BC MORPHINE SULFATE Tablet, Extended Release; 30MG ORAMORPH SR ELAN 019977 BC MORPHINE SULFATE Tablet, Extended Release; 60MG ORAMORPH SR ELAN 075295 MORPHINE SULFATE Tablet, Extended Release; 100MG MORPHINE SULFATE ENDO 075295 MORPHINE SULFATE Tablet, Extended Release; 15MG MORPHINE SULFATE ENDO 075295 MORPHINE SULFATE Tablet, Extended Release; 200MG MORPHINE SULFATE ENDO 075295 MORPHINE SULFATE Tablet, Extended Release; 30MG MORPHINE SULFATE ENDO 075295 MORPHINE SULFATE Tablet, Extended Release; 60MG MORPHINE SULFATE ENDO 076438 MORPHINE SULFATE Tablet, Extended Release; 100MG MORPHINE SULFATE Mallinckrodt 076412 MORPHINE SULFATE Tablet, Extended Release; 15MG MORPHINE SULFATE Mallinckrodt 076438 MORPHINE SULFATE Tablet, Extended Release; 200MG MORPHINE SULFATE Mallinckrodt 076412 MORPHINE SULFATE Tablet, Extended Release; 30MG MORPHINE SULFATE Mallinckrodt 076412 MORPHINE SULFATE Tablet, Extended Release; 60MG MORPHINE SULFATE Mallinckrodt 019516 MORPHINE SULFATE Tablet, Extended Release; 100MG MS CONTIN PURDUE FREDERICK 019516 MORPHINE SULFATE Tablet, Extended Release; 15MG MS CONTIN PURDUE FREDERICK 019516 MORPHINE SULFATE Tablet, Extended Release; 200MG MS CONTIN PURDUE FREDERICK 019516 MORPHINE SULFATE Tablet, Extended Release; 30MG MS CONTIN PURDUE FREDERICK 019516 MORPHINE SULFATE Tablet, Extended Release; 60MG MS CONTIN PURDUE FREDERICK 075656 MORPHINE SULFATE Tablet, Extended Release; 100MG MORPHINE SULFATE Watson DepoDur (morphine sulfate extended-release liposome injection), Skye Pharma Inc. Morphine Sulfate Extended-release Tablets, KV Pharmaceutical Morphine Sulfate Extended-release Tablets, KV Pharmaceutical Duramorph (morphine sulfate injection) and Infumorph (preservative-free morphine sulfate sterile solution), Baxter healthcare Corporation DepoDur (morphine sulfate extended-release liposome injection), Skye Pharma, Labeling Revision

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