Application 021908
- Type
- NDA
- Sponsor
- SUCAMPO PHARMA LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AMITIZA | LUBIPROSTONE | CAPSULE;ORAL | 24MCG | Yes | Yes |
| 002 | AMITIZA | LUBIPROSTONE | CAPSULE;ORAL | 8MCG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0254-3028 | Lubiprostone | Lubiprostone | Par Pharmaceutical Inc. | NDA AUTHORIZED GENERIC | Current |
| 0254-3028 | Lubiprostone | Lubiprostone | Par Pharmaceutical Inc. | NDA AUTHORIZED GENERIC | Current |
| 0254-3028 | Lubiprostone | Lubiprostone | Par Pharmaceutical Inc. | NDA AUTHORIZED GENERIC | Current |
| 0254-3029 | Lubiprostone | Lubiprostone | Par Pharmaceutical Inc. | NDA AUTHORIZED GENERIC | Current |
| 0254-3029 | Lubiprostone | Lubiprostone | Par Pharmaceutical Inc. | NDA AUTHORIZED GENERIC | Current |
| 0254-3029 | Lubiprostone | Lubiprostone | Par Pharmaceutical Inc. | NDA AUTHORIZED GENERIC | Current |
| 35356-500 | Amitiza | lubiprostone | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 35356-500 | Amitiza | lubiprostone | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 43598-163 | Lubiprostone | Lubiprostone | Dr. Reddy's Laboratories Inc. | NDA AUTHORIZED GENERIC | Current |
| 43598-168 | Lubiprostone | Lubiprostone | Dr. Reddy's Laboratories Inc. | NDA AUTHORIZED GENERIC | Current |
| 55700-963 | Lubiprostone | Lubiprostone | Quality Care Products, LLC | NDA AUTHORIZED GENERIC | Current |
| 55700-963 | Lubiprostone | Lubiprostone | Quality Care Products, LLC | NDA AUTHORIZED GENERIC | Current |
| 63304-351 | Lubiprostone | lubiprostone | Sun Pharmaceutical Industries, Inc. | NDA AUTHORIZED GENERIC | Current |
| 63304-352 | Lubiprostone | lubiprostone | Sun Pharmaceutical Industries, Inc. | NDA AUTHORIZED GENERIC | Current |
| 63629-6398 | Amitiza | lubiprostone | Bryant Ranch Prepack | NDA | Current |
| 63629-6398 | Amitiza | lubiprostone | Bryant Ranch Prepack | NDA | Current |
| 64764-080 | Amitiza | lubiprostone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-080 | Amitiza | lubiprostone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-080 | Amitiza | lubiprostone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-080 | Amitiza | lubiprostone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-080 | Amitiza | lubiprostone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-080 | Amitiza | lubiprostone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-240 | Amitiza | lubiprostone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-240 | Amitiza | lubiprostone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-240 | Amitiza | lubiprostone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-240 | Amitiza | lubiprostone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-240 | Amitiza | lubiprostone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-240 | Amitiza | lubiprostone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 68151-5003 | Amitiza | lubiprostone | Carilion Materials Management | NDA | Current |
| 69339-162 | LUBIPROSTONE | LUBIPROSTONE | DASH Pharmaceuticals LLC | NDA | Current |
| 69339-163 | LUBIPROSTONE | LUBIPROSTONE | DASH Pharmaceuticals LLC | NDA | Current |