Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205934
Company: SHILPA
Company: SHILPA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | 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 |
---|---|---|---|---|---|---|---|
12/22/2015 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205934s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205934Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205934Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/05/2023 | SUPPL-6 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205934s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205934Orig1s006ltr.pdf | |
08/04/2021 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205934s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205934Orig1s005ltr.pdf | |
02/19/2020 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205934s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205934Orig1s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/05/2023 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205934s006lbl.pdf | |
07/05/2023 | SUPPL-6 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205934s006lbl.pdf | |
08/04/2021 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205934s005lbl.pdf | |
08/04/2021 | SUPPL-5 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205934s005lbl.pdf | |
02/19/2020 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205934s003lbl.pdf | |
12/22/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205934s000lbl.pdf |
DOCETAXEL
INJECTABLE;INJECTION; 20MG/ML (20MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 201195 | ACCORD HLTHCARE |
DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 216677 | ACIC PHARMS |
DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203551 | ACTAVIS |
DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 209640 | AMNEAL |
DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 204193 | DR REDDYS |
DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 207252 | HENGRUI PHARMA |
DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 204490 | HIKMA |
DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 205934 | SHILPA |
DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210327 | SHILPA |
DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 022534 | SUN PHARM |
TAXOTERE | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 020449 | SANOFI AVENTIS US |
INJECTABLE;INJECTION; 80MG/4ML (20MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 201195 | ACCORD HLTHCARE |
DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 216677 | ACIC PHARMS |
DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203551 | ACTAVIS |
DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 209640 | AMNEAL |
DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 204193 | DR REDDYS |
DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 207252 | HENGRUI PHARMA |
DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 204490 | HIKMA |
DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 205934 | SHILPA |
DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210327 | SHILPA |
DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 022534 | SUN PHARM |
TAXOTERE | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 020449 | SANOFI AVENTIS US |
INJECTABLE;INJECTION; 160MG/8ML (20MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 201195 | ACCORD HLTHCARE |
DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203551 | ACTAVIS |
DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 209640 | AMNEAL |
DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 207252 | HENGRUI PHARMA |
DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 208137 | MYLAN LABS LTD |
DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 205934 | SHILPA |
DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210327 | SHILPA |
DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 022534 | SUN PHARM |
TAXOTERE | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 020449 | SANOFI AVENTIS US |