Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210327
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 | No | No |
| DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 05/16/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/19/2024 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/28/2020 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/28/2020 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/28/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
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 | 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 | 213768 | GUANGDONG SUNHO |
| 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 | 216677 | HERITAGE |
| 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 |
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 | 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 | 213768 | GUANGDONG SUNHO |
| 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 | 216677 | HERITAGE |
| 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 |
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 | 216677 | HERITAGE |
| 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 |
| TAXOTERE | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 020449 | SANOFI AVENTIS US |