Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075471
Company: MEITHEAL
Company: MEITHEAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEUPROLIDE ACETATE | LEUPROLIDE ACETATE | 14MG/2.8ML (1MG/0.2ML) | SOLUTION;SUBCUTANEOUS | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 10/25/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75471ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/06/2026 | SUPPL-48 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/23/2025 | SUPPL-45 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/19/2025 | SUPPL-38 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 09/19/2025 | SUPPL-37 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/19/2017 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/19/2017 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/19/2017 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2013 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/09/2012 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/28/2011 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/27/2009 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 09/20/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
LEUPROLIDE ACETATE
SOLUTION;SUBCUTANEOUS; 14MG/2.8ML (1MG/0.2ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LEUPROLIDE ACETATE | LEUPROLIDE ACETATE | 14MG/2.8ML (1MG/0.2ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 215336 | AMNEAL |
| LEUPROLIDE ACETATE | LEUPROLIDE ACETATE | 14MG/2.8ML (1MG/0.2ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 212963 | EUGIA PHARMA |
| LEUPROLIDE ACETATE | LEUPROLIDE ACETATE | 14MG/2.8ML (1MG/0.2ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 075471 | MEITHEAL |
| LEUPROLIDE ACETATE | LEUPROLIDE ACETATE | 14MG/2.8ML (1MG/0.2ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 074728 | SANDOZ |
| LEUPROLIDE ACETATE | LEUPROLIDE ACETATE | 14MG/2.8ML (1MG/0.2ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 213829 | SOMERSET THERAPS LLC |
| LEUPROLIDE ACETATE | LEUPROLIDE ACETATE | 14MG/2.8ML (1MG/0.2ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 078885 | SUN PHARM |
| LEUPROLIDE ACETATE | LEUPROLIDE ACETATE | 14MG/2.8ML (1MG/0.2ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 217957 | UBI |
| LEUPROLIDE ACETATE | LEUPROLIDE ACETATE | 14MG/2.8ML (1MG/0.2ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 215826 | ZYDUS PHARMS |