Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209165
Company: ALEMBIC PHARMS LTD
Company: ALEMBIC PHARMS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXYCYCLINE | DOXYCYCLINE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| DOXYCYCLINE | DOXYCYCLINE | EQ 100MG 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 |
|---|---|---|---|---|---|---|---|
| 07/28/2017 | 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 |
|---|---|---|---|---|---|
| 01/25/2021 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/25/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
DOXYCYCLINE
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 PHARMS LTD |
| DOXYCYCLINE | DOXYCYCLINE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204446 | COSETTE |
| DOXYCYCLINE | DOXYCYCLINE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204234 | LUPIN LTD |
| DOXYCYCLINE | DOXYCYCLINE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209396 | MAYNE PHARMA INC |
| 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 |
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 PHARMS LTD |
| DOXYCYCLINE | DOXYCYCLINE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204446 | COSETTE |
| DOXYCYCLINE | DOXYCYCLINE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204234 | LUPIN LTD |
| DOXYCYCLINE | DOXYCYCLINE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209396 | MAYNE PHARMA INC |
| DOXYCYCLINE | DOXYCYCLINE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065055 | PAR PHARM |
| 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 |
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