Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065454
Company: CHARTWELL
Company: CHARTWELL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOXYCYCLINE | DOXYCYCLINE | EQ 25MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
07/16/2008 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/065454s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/065454s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/21/2021 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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07/21/2021 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
07/21/2021 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/16/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/065454s000lbl.pdf |
DOXYCYCLINE
FOR SUSPENSION;ORAL; EQ 25MG BASE/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXYCYCLINE | DOXYCYCLINE | EQ 25MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065454 | CHARTWELL |
DOXYCYCLINE | DOXYCYCLINE | EQ 25MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 201678 | LUPIN LTD |
VIBRAMYCIN | DOXYCYCLINE | EQ 25MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 050006 | PFIZER |