Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065053
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXYCYCLINE | DOXYCYCLINE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| DOXYCYCLINE | DOXYCYCLINE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | AB | No | Yes |
| DOXYCYCLINE | DOXYCYCLINE | EQ 75MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 11/22/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65053ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/17/2026 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/17/2026 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/17/2026 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/17/2026 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/17/2026 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2014 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/14/2012 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2011 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/14/2009 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 05/20/2005 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/17/2004 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/30/2003 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/10/2003 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/10/2003 | SUPPL-4 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 12/23/2002 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 12/13/2001 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/13/2001 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
DOXYCYCLINE
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 |
| DOXYCYCLINE | DOXYCYCLINE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065055 | STRIDES PHARMA INTL |
| 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 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 |
| DOXYCYCLINE | DOXYCYCLINE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065055 | STRIDES PHARMA INTL |
| 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 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 |
| 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 |