Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205931
Company: CHARTWELL RX
Company: CHARTWELL RX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACTICLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
ACTICLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
07/25/2014 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205931s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205931Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205931Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/04/2020 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205931s005,208253s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205931Orig1s005, 208253Orig1s003ltr.pdf | |
12/26/2019 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205931s004, 208253s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205931Orig1s004, 208253Orig1s002ltr.pdf | |
11/15/2017 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205931s003,208253s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205931Orig1s003,208253Orig1s001ltr.pdf |
04/26/2016 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205931s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205931Orig1s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/04/2020 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205931s005,208253s003lbl.pdf | |
12/26/2019 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205931s004, 208253s002lbl.pdf | |
11/15/2017 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205931s003,208253s001lbl.pdf |
04/26/2016 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205931s002lbl.pdf | |
07/25/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205931s000lbl.pdf |
ACTICLATE
TABLET;ORAL; EQ 75MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ACTICLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET;ORAL | Prescription | Yes | AB | 205931 | CHARTWELL RX |
DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 211584 | AJANTA PHARMA LTD |
DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 211744 | ALEMBIC |
DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 209243 | APOTEX |
DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 208765 | DR REDDYS LABS SA |
DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 214207 | EPIC PHARMA LLC |
DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 208818 | LUPIN LTD |
TABLET;ORAL; EQ 150MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ACTICLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET;ORAL | Prescription | Yes | AB | 205931 | CHARTWELL RX |
DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 211584 | AJANTA PHARMA LTD |
DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 211744 | ALEMBIC |
DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 209243 | APOTEX |
DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 208765 | DR REDDYS LABS SA |
DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 214207 | EPIC PHARMA LLC |
DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 208818 | LUPIN LTD |