Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEUPROLIDE ACETATE | LEUPROLIDE ACETATE | 1MG/0.2ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
08/04/1998 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74728ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74728.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/01/2021 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
02/01/2021 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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05/19/2017 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
05/19/2017 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
11/17/2015 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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09/27/2011 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/074728s011lbl.pdf | |
03/28/2011 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
07/06/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
09/13/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
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04/03/2001 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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11/18/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/27/2011 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/074728s011lbl.pdf |
LEUPROLIDE ACETATE
INJECTABLE;INJECTION; 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 | 1MG/0.2ML | INJECTABLE;INJECTION | Prescription | No | AP | 215336 | AMNEAL |
LEUPROLIDE ACETATE | LEUPROLIDE ACETATE | 1MG/0.2ML | INJECTABLE;INJECTION | Prescription | No | AP | 212963 | EUGIA PHARMA |
LEUPROLIDE ACETATE | LEUPROLIDE ACETATE | 1MG/0.2ML | INJECTABLE;INJECTION | Prescription | No | AP | 075471 | MEITHEAL |
LEUPROLIDE ACETATE | LEUPROLIDE ACETATE | 1MG/0.2ML | INJECTABLE;INJECTION | Prescription | No | AP | 213829 | RK PHARMA |
LEUPROLIDE ACETATE | LEUPROLIDE ACETATE | 1MG/0.2ML | INJECTABLE;INJECTION | Prescription | No | AP | 074728 | SANDOZ |
LEUPROLIDE ACETATE | LEUPROLIDE ACETATE | 1MG/0.2ML | INJECTABLE;INJECTION | Prescription | No | AP | 078885 | SUN PHARM |