Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065277
Company: CHARTWELL MOLECULAR
Company: CHARTWELL MOLECULAR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 20MG BASE | TABLET;ORAL | Prescription | AB | No | 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 |
---|---|---|---|---|---|---|---|
11/10/2005 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/13/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
DOXYCYCLINE HYCLATE
TABLET;ORAL; EQ 20MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 210537 | ALEMBIC |
DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 065277 | CHARTWELL MOLECULAR |
DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 065182 | EPIC PHARMA LLC |
DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 065287 | LARKEN LABS |
DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 065134 | SUN PHARM INDUSTRIES |