docetaxel Injectable Solution
- Brand(s)
- Docefrez, Taxotere
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Actavis Inc. (2015-02-19)
- Oldest Current Product
- 2010-08-02
- License(s)
- NDA, ANDA
- RxNORM
- INJECTABLE SOLUTION\DOCETAXEL
- FDAOB
- INJECTION\INJECTION\DOCETAXEL\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\DOCETAXEL
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\DOCETAXEL ANHYDROUS
INTRAVENOUS\INJECTION, SOLUTION\DOCETAXEL
INTRAVENOUS\INJECTION, SOLUTION\DOCETAXEL ANHYDROUS
INTRAVENOUS\SOLUTION\DOCETAXEL - SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\DOCETAXEL ANHYDROUS
INTRAVENOUS\INJECTION, SOLUTION\DOCETAXEL ANHYDROUS
INTRAVENOUS\SOLUTION\DOCETAXEL ANHYDROUS
product(s) by strength(s)
docetaxel 10 mg/ml injectable solution
original product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000699142 | NDA | Pfizer Labs | 2014-06-23 | DOCETAXEL ANHYDROUS | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | NDA202356 | d2dc690b-4c69-428a-a67e-8ad007c39548 |
| 2 | 000699144 | NDA | Pfizer Labs | 2014-06-23 | DOCETAXEL ANHYDROUS | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | NDA202356 | d2dc690b-4c69-428a-a67e-8ad007c39548 |
| 3 | 004090201 | NDA | Hospira, Inc. | 2011-03-08 | DOCETAXEL ANHYDROUS | INTRAVENOUS | INJECTION, SOLUTION | NDA022234 | a0ec4bcc-93ea-4c41-a4b6-95ec19491807 |
docetaxel 20 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000758003 | Taxotere | NDA | Sanofi-Aventis U.S. Llc | 2010-08-02 | DOCETAXEL | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | NDA020449 | 45e6dce4-92e2-4ad1-bf11-bbcefb753636 |
| 2 | 009551021 | NDA | Winthrop U.S. | 2010-10-21 | DOCETAXEL | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | NDA020449 | dd0ca36d-1f54-4568-8d19-a7152addcd52 | |
| 3 | 167290231 | NDA | Accord Healthcare Inc. | 2012-07-01 | DOCETAXEL | INTRAVENOUS | INJECTION, SOLUTION | NDA201195 | f59f7811-70b7-4c44-99f7-4f4fdce3ed22 | |
| 4 | 250210222 | NDA | Sagent Pharmaceuticals | 2013-07-01 | DOCETAXEL | INTRAVENOUS | SOLUTION | NDA203551 | 70aeb960-426c-4805-b956-476bebccd926 | |
| 5 | 459630765 | NDA | Actavis Inc. | 2014-09-01 | DOCETAXEL | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | NDA203551 | 2c806400-5fdc-4398-8475-37f700b3191f | |
| 6 | 459630790 | NDA | Actavis Inc. | 2015-10-13 | DOCETAXEL | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | NDA203551 | 2c806400-5fdc-4398-8475-37f700b3191f | |
| 7 | 637390971 | NDA | Mckesson Packaging Services A Business Unit Of Mckesson Corporation | 2011-06-08 | DOCETAXEL ANHYDROUS | INTRAVENOUS | INJECTION, SOLUTION | NDA201195 | c482c813-1eb7-40dd-907a-845a7df112bf |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 435980258 | ANDA | Dr. Reddy'S Laboratories Inc | 2014-11-10 | DOCETAXEL | INTRAVENOUS | INJECTION, SOLUTION | ANDA204193 | a630937b-8369-74ad-b68a-f940eb16ff0f |
| 2 | 435980259 | ANDA | Dr. Reddy'S Laboratories Inc | 2014-11-10 | DOCETAXEL | INTRAVENOUS | INJECTION, SOLUTION | ANDA204193 | a630937b-8369-74ad-b68a-f940eb16ff0f |
docetaxel 25 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 473350285 | Docefrez | NDA | Sun Pharma Global Fze | 2011-05-03 | DOCETAXEL ANHYDROUS | KIT | NDA022534 | b35e3633-8893-4b0b-af1e-92e342557199 |
docetaxel 40 mg/ml injectable solution
original product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 167290228 | NDA | Accord Healthcare Inc. | 2011-06-30 | DOCETAXEL | INTRAVENOUS | INJECTION, SOLUTION | NDA201195 | f59f7811-70b7-4c44-99f7-4f4fdce3ed22 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA203877 | DOCETAXEL | TEVA PHARMACEUTICALS USA | 2015-09-16 | ANDA203877_001, ANDA203877_002 | |
| 2 | ANDA204193 | DOCETAXEL | DR REDDYS LABORATORIES LTD | 2014-11-05 | ANDA204193_001, ANDA204193_002 | |
| 3 | NDA020449 | TAXOTERE | SANOFI AVENTIS US LLC | 1996-05-14 | NDA020449_001, NDA020449_003, NDA020449_004, NDA020449_005 | |
| 4 | NDA022234 | DOCETAXEL | HOSPIRA INC | 2011-03-08 | NDA022234_001, NDA022234_002, NDA022234_003 | |
| 5 | NDA022312 | DOCETAXEL | True | APOTEX INC | 2012-01-11 | NDA022312_001, NDA022312_002 |
| 6 | NDA022534 | DOCEFREZ | SUN PHARMA GLOBAL FZE | 2011-05-03 | NDA022534_001, NDA022534_002 | |
| 7 | NDA201195 | DOCETAXEL | ACCORD HEALTHCARE INC | 2011-06-08 | NDA201195_001, NDA201195_002, NDA201195_003, NDA201195_004, NDA201195_005 | |
| 8 | NDA201525 | DOCETAXEL | SANDOZ | 2011-06-29 | NDA201525_001, NDA201525_002, NDA201525_003 | |
| 9 | NDA202356 | DOCETAXEL | PFIZER LABS | 2014-03-13 | NDA202356_001, NDA202356_002, NDA202356_003, NDA202356_004 | |
| 10 | NDA203551 | DOCETAXEL | ACTAVIS INC | 2013-04-12 | NDA203551_001, NDA203551_002, NDA203551_003 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA203877_001 | RX | DOCETAXEL (20MG/ML) | INJECTION | False | AP | 2015-09-16 | DOCETAXEL |
| 2 | ANDA203877_002 | RX | DOCETAXEL (80MG/4ML) | INJECTION | False | AP | 2015-09-16 | DOCETAXEL |
| 3 | ANDA204193_001 | RX | DOCETAXEL (20MG/ML) | INJECTION | False | AP | 2014-11-05 | DOCETAXEL |
| 4 | ANDA204193_002 | RX | DOCETAXEL (80MG/4ML) | INJECTION | False | AP | 2014-11-05 | DOCETAXEL |
| 5 | NDA020449_001 | discontinued | DOCETAXEL (40MG/ML) | INJECTION | False | 1996-05-14 | TAXOTERE | |
| 6 | NDA020449_003 | RX | DOCETAXEL (20MG/ML) | INJECTION | True | AP | 2010-08-03 | TAXOTERE |
| 7 | NDA020449_004 | RX | DOCETAXEL (80MG/4ML) | INJECTION | True | AP | 2010-08-02 | TAXOTERE |
| 8 | NDA020449_005 | RX | DOCETAXEL (160MG/8ML) | INJECTION | True | AP | 2012-04-13 | TAXOTERE |
| 9 | NDA022234_001 | RX | DOCETAXEL (20MG/2ML) | INJECTION | True | AP | 2011-03-08 | DOCETAXEL |
| 10 | NDA022234_002 | RX | DOCETAXEL (80MG/8ML) | INJECTION | True | AP | 2011-03-08 | DOCETAXEL |
| 11 | NDA022234_003 | RX | DOCETAXEL (160MG/16ML) | INJECTION | True | AP | 2011-03-08 | DOCETAXEL |
| 12 | NDA022312_001 | discontinued | DOCETAXEL (20MG/0.5ML) | INJECTION | False | 2012-01-11 | DOCETAXEL | |
| 13 | NDA022312_002 | discontinued | DOCETAXEL (80MG/2ML) | INJECTION | False | 2012-01-11 | DOCETAXEL | |
| 14 | NDA022534_001 | RX | DOCETAXEL (20MG/VIAL) | INJECTION | True | 2011-05-03 | DOCEFREZ | |
| 15 | NDA022534_002 | RX | DOCETAXEL (80MG/VIAL) | INJECTION | True | 2011-05-03 | DOCEFREZ | |
| 16 | NDA201195_001 | RX | DOCETAXEL (20MG/0.5ML) | INJECTION | False | 2011-06-08 | DOCETAXEL | |
| 17 | NDA201195_002 | RX | DOCETAXEL (80MG/2ML) | INJECTION | False | 2011-06-08 | DOCETAXEL | |
| 18 | NDA201195_003 | RX | DOCETAXEL (20MG/ML) | INJECTION | False | AP | 2012-04-20 | DOCETAXEL |
| 19 | NDA201195_004 | RX | DOCETAXEL (80MG/4ML) | INJECTION | False | AP | 2012-04-20 | DOCETAXEL |
| 20 | NDA201195_005 | RX | DOCETAXEL (160MG/8ML) | INJECTION | True | AP | 2012-04-20 | DOCETAXEL |
| 21 | NDA201525_001 | RX | DOCETAXEL (20MG/2ML) | INJECTION | False | AP | 2011-06-29 | DOCETAXEL |
| 22 | NDA201525_002 | RX | DOCETAXEL (80MG/8ML) | INJECTION | False | AP | 2011-06-29 | DOCETAXEL |
| 23 | NDA201525_003 | RX | DOCETAXEL (160MG/16ML) | INJECTION | False | AP | 2011-06-29 | DOCETAXEL |
| 24 | NDA202356_001 | RX | DOCETAXEL (20MG/2ML) | INJECTION | False | 2014-03-13 | DOCETAXEL | |
| 25 | NDA202356_002 | RX | DOCETAXEL (80MG/8ML) | INJECTION | False | 2014-03-13 | DOCETAXEL | |
| 26 | NDA202356_003 | RX | DOCETAXEL (130MG/13ML) | INJECTION | False | 2014-03-13 | DOCETAXEL | |
| 27 | NDA202356_004 | RX | DOCETAXEL (200MG/20ML) | INJECTION | False | 2014-03-13 | DOCETAXEL | |
| 28 | NDA203551_001 | RX | DOCETAXEL (20MG/ML) | INJECTION | False | AP | 2013-04-12 | DOCETAXEL |
| 29 | NDA203551_002 | RX | DOCETAXEL (80MG/4ML) | INJECTION | False | AP | 2013-04-12 | DOCETAXEL |
| 30 | NDA203551_003 | RX | DOCETAXEL (140MG/7ML) | INJECTION | False | 2013-04-12 | DOCETAXEL |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 2c806400-5fdc-4398-8475-37f700b3191f (view SPL) | These highlights do not include all the information needed to use docetaxel injection concentrate safely and effectively. See full prescribing information for docetaxel injection concentrate. DOCETAXEL injection concentrate, for intravenous infusion (IV) Initial U.S. Approval: 1996 | prescription | Human Prescription | Actavis Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-02-19 | 25 | 459630765, 459630790, 459630734, 459630781 |
| 2 | 45e6dce4-92e2-4ad1-bf11-bbcefb753636 (view SPL) | These highlights do not include all the information needed to use TAXOTERE safely and effectively. See full prescribing information for TAXOTERE. TAXOTERE (docetaxel) Injection Concentrate, Intravenous Infusion (IV). Initial U.S. Approval: 1996 | prescription | Human Prescription | Sanofi-Aventis U.S. Llc | ANALYSIS, LABEL, MANUFACTURE, PACK | 2014-11-20 | 13 | 000758003, 000758004 |
| 3 | 70aeb960-426c-4805-b956-476bebccd926 (view SPL) | These highlights do not include all the information needed to use docetaxel injection concentrate safely and effectively. See full prescribing information for docetaxel injection concentrate. Docetaxel Injection ConcentrateIntravenous Infusion (IV) Initial U.S. Approval: 1996 | prescription | Human Prescription | Sagent Pharmaceuticals | 2013-11-06 | 3 | 250210222 | |
| 4 | 875b764f-10b2-448d-b50b-c9e8c1cfd69a (view SPL) | These highlights do not include all the information needed to use Docetaxel Injection safely and effectively. See full prescribing information for Docetaxel Injection. DOCETAXEL INJECTION, Solution for Intravenous Infusion Initial U.S. Approval: 1996 | prescription | Human Prescription | Sandoz Inc | 2014-10-15 | 1 | 667580950 | |
| 5 | a0ec4bcc-93ea-4c41-a4b6-95ec19491807 (view SPL) | These highlights do not include all the information needed to use DOCETAXEL INJECTION safely and effectively. See full prescribing information for DOCETAXEL INJECTION. DOCETAXEL INJECTION For intravenous infusion only. Initial U.S. Approval: 1996 | prescription | Human Prescription | Hospira, Inc. | 2014-07-22 | 22 | 004090201 | |
| 6 | a630937b-8369-74ad-b68a-f940eb16ff0f (view SPL) | ONE-VIAL FORMULATION These highlights do not include all the information needed to use docetaxel injection safety and effectively. See full prescribing information for docetaxel injection USP ONE- VIAL FORMULATION Docetaxel Injection, Intravenous Infusion (IV). Initial U.S. Approval: 1996 | prescription | Human Prescription | Dr. Reddy'S Laboratories Inc | analysis, manufacture | 2014-12-15 | 7 | 435980258, 435980259 |
| 7 | b35e3633-8893-4b0b-af1e-92e342557199 (view SPL) | These highlights do not include all the information needed to use DOCEFREZ safely and effectively. See full prescribing information for DOCEFREZ. DOCEFREZ (docetaxel) for Injection, Intravenous InfusionInitial U.S. Approval: 1996 | prescription | Human Prescription | Sun Pharma Global Fze | ANALYSIS, MANUFACTURE | 2014-11-13 | 10 | 473350285 |
| 8 | c482c813-1eb7-40dd-907a-845a7df112bf (view SPL) | These highlights do not include all the information needed to use DOCETAXEL INJECTION safely and effectively. See full prescribing information for DOCETAXEL INJECTION DOCETAXEL INJECTION, Intravenous Infusion. Initial U.S. Approval: 1996 | prescription | Human Prescription | Mckesson Packaging Services A Business Unit Of Mckesson Corporation | ANALYSIS, MANUFACTURE | 2015-03-12 | 5 | 637390971, 637390932 |
| 9 | d2dc690b-4c69-428a-a67e-8ad007c39548 (view SPL) | These highlights do not include all the information needed to use DOCETAXEL INJECTION safely and effectively. See full prescribing information for DOCETAXEL INJECTION. DOCETAXEL INJECTION, Intravenous Infusion.Initial U.S. Approval: 1996 | prescription | Human Prescription | Pfizer Labs | ANALYSIS, LABEL, MANUFACTURE, PACK | 2014-12-24 | 2 | 000699142, 000699144, 000699141 |
| 10 | dd0ca36d-1f54-4568-8d19-a7152addcd52 (view SPL) | These highlights do not include all the information needed to use docetaxel safely and effectively. See full prescribing information for docetaxel. Docetaxel Injection Concentrate, Intravenous Infusion (IV). Initial U.S. Approval: 1996 | prescription | Human Prescription | Winthrop U.S. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2014-11-21 | 11 | 009551021, 009551020 |
| 11 | e03d1378-6889-43d5-a34c-f96132cffa88 (view SPL) | These highlights do not include all the information needed to use Docetaxel Injection safely and effectively. See full prescribing information for Docetaxel Injection. DOCETAXEL INJECTION, Solution for Intravenous Infusion Initial U.S. Approval: 1996 | prescription | Human Prescription | Sandoz Inc | 2014-07-11 | 5 | 667580050 | |
| 12 | f59f7811-70b7-4c44-99f7-4f4fdce3ed22 (view SPL) | These highlights do not include all the information needed to use DOCETAXEL INJECTION safely and effectively. See full prescribing information for DOCETAXEL INJECTION DOCETAXEL INJECTION, Intravenous Infusion. Initial U.S. Approval: 1996 | prescription | Human Prescription | Accord Healthcare Inc. | ANALYSIS, MANUFACTURE | 2014-09-22 | 10 | 167290228, 167290231, 167290120, 167290267 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII