Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076095
Company: ANI PHARMS
Company: ANI PHARMS
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 |
---|---|---|---|---|---|---|---|
07/10/2002 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76095ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076095.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/14/2022 | SUPPL-15 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
01/27/2010 | SUPPL-12 | Labeling-Medication Guide |
Label is not available on this site. |
||
12/27/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
11/20/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
11/20/2002 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
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 |