Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075671
Company: STRIDES PHARMA
Company: STRIDES PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEGESTROL ACETATE | MEGESTROL ACETATE | 40MG/ML | SUSPENSION;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/25/2001 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-671_Megestrol%20Acetate.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75671ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-671_Megestrol%20Acetate.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/19/2020 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/16/2013 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/04/2004 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/23/2004 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/14/2003 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/01/2002 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
MEGESTROL ACETATE
SUSPENSION;ORAL; 40MG/ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MEGESTROL ACETATE | MEGESTROL ACETATE | 40MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 075671 | STRIDES PHARMA |