Drugs@FDA: FDA-Approved Drugs
Company: CHARTWELL RX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MONODOX | DOXYCYCLINE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | No |
MONODOX | DOXYCYCLINE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | No |
MONODOX | DOXYCYCLINE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | No |
MONODOX | DOXYCYCLINE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | 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 |
---|---|---|---|---|---|---|---|
12/29/1989 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
05/08/2024 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050641s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/050641Orig1s033ltr.pdf | |
02/17/2022 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050641Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050641Orig1s032ltr.pdf | |
04/03/2017 | SUPPL-29 | 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/2017/050641s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050641Orig1s029ltr.pdf |
08/05/2016 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/11/2013 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050641s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050641Orig1s027ltr.pdf | |
03/08/2011 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050641s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050641s026ltr.pdf | |
01/11/2012 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050641s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050641s018ltr.pdf | |
12/20/2007 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050641s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050641s014ltr.pdf | |
01/31/2007 | SUPPL-13 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050641s013ltr.pdf |
06/18/2002 | SUPPL-10 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50641s010ltr.pdf |
03/21/2002 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50641s8ltr.pdf |
01/07/1994 | SUPPL-7 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
06/24/1992 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
03/06/1992 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
11/15/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
02/10/1992 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/25/1991 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/15/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/08/2024 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050641s033lbl.pdf | |
02/17/2022 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050641Orig1s032lbl.pdf | |
04/03/2017 | SUPPL-29 | 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/2017/050641s029lbl.pdf |
10/11/2013 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050641s027lbl.pdf | |
01/11/2012 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050641s018lbl.pdf | |
03/08/2011 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050641s026lbl.pdf | |
12/20/2007 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050641s014lbl.pdf |
MONODOX
CAPSULE;ORAL; EQ 100MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXYCYCLINE | DOXYCYCLINE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209165 | ALEMBIC |
DOXYCYCLINE | DOXYCYCLINE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209396 | DR REDDYS LABS SA |
DOXYCYCLINE | DOXYCYCLINE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204234 | LUPIN LTD |
DOXYCYCLINE | DOXYCYCLINE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065055 | STRIDES PHARMA |
DOXYCYCLINE | DOXYCYCLINE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065053 | SUN PHARM INDS LTD |
DOXYCYCLINE | DOXYCYCLINE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 205115 | ZYDUS PHARMS |
MONODOX | DOXYCYCLINE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050641 | CHARTWELL RX |
CAPSULE;ORAL; EQ 50MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXYCYCLINE | DOXYCYCLINE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209396 | DR REDDYS LABS SA |
DOXYCYCLINE | DOXYCYCLINE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204234 | LUPIN LTD |
DOXYCYCLINE | DOXYCYCLINE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065055 | STRIDES PHARMA |
DOXYCYCLINE | DOXYCYCLINE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065053 | SUN PHARM INDS LTD |
DOXYCYCLINE | DOXYCYCLINE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 205115 | ZYDUS PHARMS |
MONODOX | DOXYCYCLINE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050641 | CHARTWELL RX |
CAPSULE;ORAL; EQ 75MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXYCYCLINE | DOXYCYCLINE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209165 | ALEMBIC |
DOXYCYCLINE | DOXYCYCLINE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209396 | DR REDDYS LABS SA |
DOXYCYCLINE | DOXYCYCLINE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204234 | LUPIN LTD |
DOXYCYCLINE | DOXYCYCLINE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065053 | SUN PHARM INDS LTD |
DOXYCYCLINE | DOXYCYCLINE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 205115 | ZYDUS PHARMS |
MONODOX | DOXYCYCLINE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050641 | CHARTWELL RX |
CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXYCYCLINE | DOXYCYCLINE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065055 | STRIDES PHARMA |
MONODOX | DOXYCYCLINE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050641 | CHARTWELL RX |