Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209450
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LUBIPROSTONE | LUBIPROSTONE | 8MCG | CAPSULE;ORAL | Prescription | AB | No | No |
LUBIPROSTONE | LUBIPROSTONE | 24MCG | CAPSULE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
11/30/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209450Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/05/2022 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
LUBIPROSTONE
CAPSULE;ORAL; 8MCG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMITIZA | LUBIPROSTONE | 8MCG | CAPSULE;ORAL | Prescription | Yes | AB | 021908 | SUCAMPO PHARMA LLC |
LUBIPROSTONE | LUBIPROSTONE | 8MCG | CAPSULE;ORAL | Prescription | No | AB | 209450 | AMNEAL |
LUBIPROSTONE | LUBIPROSTONE | 8MCG | CAPSULE;ORAL | Prescription | No | AB | 206994 | DR REDDYS |
LUBIPROSTONE | LUBIPROSTONE | 8MCG | CAPSULE;ORAL | Prescription | No | AB | 209920 | TEVA PHARMS USA INC |
LUBIPROSTONE | LUBIPROSTONE | 8MCG | CAPSULE;ORAL | Prescription | No | AB | 214131 | ZYDUS PHARMS |
CAPSULE;ORAL; 24MCG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMITIZA | LUBIPROSTONE | 24MCG | CAPSULE;ORAL | Prescription | Yes | AB | 021908 | SUCAMPO PHARMA LLC |
LUBIPROSTONE | LUBIPROSTONE | 24MCG | CAPSULE;ORAL | Prescription | No | AB | 209450 | AMNEAL |
LUBIPROSTONE | LUBIPROSTONE | 24MCG | CAPSULE;ORAL | Prescription | No | AB | 206994 | DR REDDYS |
LUBIPROSTONE | LUBIPROSTONE | 24MCG | CAPSULE;ORAL | Prescription | No | AB | 209920 | TEVA PHARMS USA INC |
LUBIPROSTONE | LUBIPROSTONE | 24MCG | CAPSULE;ORAL | Prescription | No | AB | 214131 | ZYDUS PHARMS |