Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216872
Company: MICRO LABS
Company: MICRO LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MISOPROSTOL | MISOPROSTOL | 0.1MG | TABLET;ORAL | Prescription | AB | No | No |
MISOPROSTOL | MISOPROSTOL | 0.2MG | TABLET;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 |
---|---|---|---|---|---|---|---|
10/17/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
MISOPROSTOL
TABLET;ORAL; 0.1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CYTOTEC | MISOPROSTOL | 0.1MG | TABLET;ORAL | Prescription | Yes | AB | 019268 | PFIZER |
MISOPROSTOL | MISOPROSTOL | 0.1MG | TABLET;ORAL | Prescription | No | AB | 076095 | ANI PHARMS |
MISOPROSTOL | MISOPROSTOL | 0.1MG | TABLET;ORAL | Prescription | No | AB | 216872 | MICRO LABS |
TABLET;ORAL; 0.2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CYTOTEC | MISOPROSTOL | 0.2MG | TABLET;ORAL | Prescription | Yes | AB | 019268 | PFIZER |
MISOPROSTOL | MISOPROSTOL | 0.2MG | TABLET;ORAL | Prescription | No | AB | 076095 | ANI PHARMS |
MISOPROSTOL | MISOPROSTOL | 0.2MG | TABLET;ORAL | Prescription | No | AB | 216872 | MICRO LABS |