Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075185
Company: CARLSBAD
Company: CARLSBAD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE;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 |
---|---|---|---|---|---|---|---|
11/13/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75185ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/09/2016 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
08/24/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
02/18/2010 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
02/23/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
11/19/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |
DICLOFENAC SODIUM
TABLET, DELAYED RELEASE;ORAL; 75MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 074514 | ACTAVIS ELIZABETH |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 075185 | CARLSBAD |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 077863 | UNIQUE PHARM LABS |
TABLET, DELAYED RELEASE;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 075185 | CARLSBAD |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090066 | UNIQUE PHARM LABS |
TABLET, DELAYED RELEASE;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 074514 | ACTAVIS ELIZABETH |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 075185 | CARLSBAD |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090066 | UNIQUE PHARM LABS |
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