olanzapine Injection
- Brand(s)
- Zyprexa
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Eli Lilly And Company (2015-09-04)
- Oldest Current Product
- 2004-04-01
- License(s)
- NDA, ANDA
- RxNORM
- INJECTION\OLANZAPINE
- FDAOB
- INTRAMUSCULAR\INJECTION\OLANZAPINE
INTRAMUSCULAR\SUSPENSION, EXTENDED RELEASE\OLANZAPINE PAMOATE - SPL Active
- INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\OLANZAPINE
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\OLANZAPINE - SPL Moiety
- INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\OLANZAPINE
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\OLANZAPINE
product(s) by strength(s)
olanzapine 10 mg injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000027597 | Zyprexa | NDA | Eli Lilly And Company | 2004-04-01 | OLANZAPINE | INTRAMUSCULAR | INJECTION, POWDER, FOR SOLUTION | NDA021253 | d5051fbc-846b-4946-82df-341fb1216341 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 005170955 | ANDA | American Regent, Inc. | 2012-06-27 | OLANZAPINE | INTRAMUSCULAR | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA201741 | e9ac2bd3-dbff-4b1a-952f-da3909c6e4ee |
| 2 | 007813159 | ANDA | Sandoz Inc | 2011-10-24 | OLANZAPINE | INTRAMUSCULAR | INJECTION, POWDER, FOR SOLUTION | ANDA201588 | 1e9666ef-4271-4834-8496-ccb3125d83db |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 647250955 | ANDA | Tya Pharmaceuticals | 2012-06-27 | OLANZAPINE | INTRAMUSCULAR | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 005170955 | ANDA201741 | 591f9bb1-f119-4739-87b0-de29c9446727 |
| 2 | 647253159 | ANDA | Tya Pharmaceuticals | 2011-10-24 | OLANZAPINE | INTRAMUSCULAR | INJECTION, POWDER, FOR SOLUTION | 007813159 | ANDA201588 | 3b3bc948-161e-49ee-b67f-4bbb63af23d6 |
olanzapine 210 mg injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | application | spl |
|---|---|---|---|---|---|---|---|
| 1 | 000027635 | Zyprexa | NDA | Eli Lilly And Company | 2010-03-01 | NDA022173 | f9a73185-88de-4d7b-b3c0-bbf231483241 |
olanzapine 300 mg injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | application | spl |
|---|---|---|---|---|---|---|---|
| 1 | 000027636 | Zyprexa | NDA | Eli Lilly And Company | 2010-03-01 | NDA022173 | f9a73185-88de-4d7b-b3c0-bbf231483241 |
olanzapine 405 mg injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | application | spl |
|---|---|---|---|---|---|---|---|
| 1 | 000027637 | Zyprexa | NDA | Eli Lilly And Company | 2010-03-01 | NDA022173 | f9a73185-88de-4d7b-b3c0-bbf231483241 |
application(s)
| # | id | title | applicant | approved | patent | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA201588 | OLANZAPINE | SANDOZ INC | 2011-10-24 | ANDA201588_001 | |
| 2 | ANDA201741 | OLANZAPINE | LUITPOLD PHARMACEUTICALS INC | 2012-03-20 | ANDA201741_001 | |
| 3 | NDA021253 | ZYPREXA | ELI LILLY AND CO | 2004-03-29 | NDA021253_001 | |
| 4 | NDA022173 | ZYPREXA RELPREVV | ELI LILLY CO | 2009-12-11 | p6169084, A METHOD OF TREATING HUMAN SUFFERING FROM OR SUSCEPTIBLE TO PSYCHOSIS., SUBSTANCE | NDA022173_001, NDA022173_002, NDA022173_003 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA201588_001 | RX | OLANZAPINE (10MG/VIAL) | INTRAMUSCULAR | INJECTION | False | AP | 2011-10-24 | OLANZAPINE |
| 2 | ANDA201741_001 | RX | OLANZAPINE (10MG/VIAL) | INTRAMUSCULAR | INJECTION | False | AP | 2012-03-20 | OLANZAPINE |
| 3 | NDA021253_001 | RX | OLANZAPINE (10MG/VIAL) | INTRAMUSCULAR | INJECTION | True | AP | 2004-03-29 | ZYPREXA |
| 4 | NDA022173_001 | RX | OLANZAPINE PAMOATE (EQ 210MG BASE/VIAL) | INTRAMUSCULAR | SUSPENSION, EXTENDED RELEASE | False | 2009-12-11 | ZYPREXA RELPREVV | |
| 5 | NDA022173_002 | RX | OLANZAPINE PAMOATE (EQ 300MG BASE/VIAL) | INTRAMUSCULAR | SUSPENSION, EXTENDED RELEASE | False | 2009-12-11 | ZYPREXA RELPREVV | |
| 6 | NDA022173_003 | RX | OLANZAPINE PAMOATE (EQ 405MG BASE/VIAL) | INTRAMUSCULAR | SUSPENSION, EXTENDED RELEASE | True | 2009-12-11 | ZYPREXA RELPREVV |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p6169084 (view patent) | 2018-09-30 | NDA022173 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 1e9666ef-4271-4834-8496-ccb3125d83db (view SPL) | These highlights do not include all the information needed to use olanzapine for injection safely and effectively. See full prescribing information for olanzapine for injection. OLANZAPINE for injection, powder, for solution for intramuscular useInitial U.S. Approval: 1996 | prescription | Human Prescription | Sandoz Inc | 2015-07-30 | 4 | 007813159 | ||
| 2 | 3b3bc948-161e-49ee-b67f-4bbb63af23d6 (view SPL) | These highlights do not include all the information needed to use Olanzapine for Injection safely and effectively. See full prescribing information for Olanzapine for Injection. Olanzapine for Injection, Powder, For Solution for Intramuscular use Initial U.S. Approval: 1996 | prescription | Human Prescription | Tya Pharmaceuticals | RELABEL, REPACK | 2011-11-02 | 2 | 647253159 | |
| 3 | 591f9bb1-f119-4739-87b0-de29c9446727 (view SPL) | These highlights do not include all the information needed to use Olanzapine safely and effectively. See full prescribing information for Olanzapine. Olanzapine (Olanzapine) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION for INTRAMUSCULAR use. Initial U.S. Approval: 2012 | prescription | Human Prescription | Tya Pharmaceuticals | RELABEL, REPACK | 2012-07-05 | 2 | 647250955 | |
| 4 | d5051fbc-846b-4946-82df-341fb1216341 (view SPL) | These highlights do not include all the information needed to use ZYPREXA safely and effectively. See full prescribing information for ZYPREXA. ZYPREXA (olanzapine) Tablet for Oral use ZYPREXA ZYDIS (olanzapine) Tablet, Orally Disintegrating for Oral use ZYPREXA IntraMuscular (olanzapine) Injection, Powder, For Solution for Intramuscular use Initial U.S. Approval: 1996 | prescription | Human Prescription | Eli Lilly And Company | 2015-07-23 | 45 | 000027597, 000024112, 000024115, 000024116, 000024117, 000024415, 000024420, 000024453, 000024454, 000024455, 000024456 | olanzapine Oral Tablet olanzapine Disintegrating Oral Tablet | |
| 5 | e9ac2bd3-dbff-4b1a-952f-da3909c6e4ee (view SPL) | These highlights do not include all the information needed to use Olanzapine safely and effectively. See full prescribing information for Olanzapine. Olanzapine (Olanzapine) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION for INTRAMUSCULAR use.Initial U.S. Approval: 2012 | prescription | Human Prescription | American Regent, Inc. | 2012-07-05 | 4 | 005170955 | ||
| 6 | f9a73185-88de-4d7b-b3c0-bbf231483241 (view SPL) | These highlights do not include all the information needed to use ZYPREXA RELPREVV safely and effectively. See full prescribing information for ZYPREXA RELPREVV.ZYPREXA RELPREVV (olanzapine) For Extended Release Injectable SuspensionInitial U.S. Approval: 1996 | prescription | Human Prescription | Eli Lilly And Company | 2015-09-04 | 45 | 000027635, 000027636, 000027637 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII