Drug company (FDA labeler)
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
NDC labeler code: 0168
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Triamcinolone acetonideKenalog-40, Triderm, Triesence · 5 products
- Betamethasone dipropionateDiprolene, Sernivo · 5 products
- HydrocortisoneSolu-Cortef, Proctozone-Hc, Alkindi Sprinkle · 4 products
- ClindamycinCleocin Phosphate, Cleocin Hydrochloride, Clindamycin Phoaphate Topical Solution Usp, 1% · 4 products
- Betamethasone valerate3 products
- TacrolimusPrograf, Envarsus XR, Astagraf XL · 2 products
- TerconazoleTerconazole Vaginal Cream 0.8% · 2 products
- KetoconazoleKetodan · 1 product
- Oxiconazole nitrateOxistat · 1 product
- AdapaleneDifferin · 1 product
- Fluocinonide1 product
- Fluocinolone acetonideFluocinolone Acetonide Oil, Derma-Smoothe/Fs, Synalar · 1 product
- Clotrimazole and betamethasone dipropionate1 product
- Clobetasol propionateClobetasol Propionate (Emollient), Byqlovi, Tovet (Emollient Formulation) · 1 product
- Lidocaine and prilocaineOraqix · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| September 9, 2014 | ANDA200744 | Tacrolimus TACROLIMUS | Fougera Pharms Inc |
| June 30, 2010 | ANDA090824 | Adapalene ADAPALENE | Fougera Pharms |
| May 21, 2007 | ANDA077111 | Betamethasone dipropionate BETAMETHASONE DIPROPIONATE | Fougera Pharms |
| February 18, 2005 | ANDA076712 | Terconazole TERCONAZOLE | Fougera Pharms |
| December 27, 2004 | ANDA065139 | Clindamycin CLINDAMYCIN PHOSPHATE | Fougera Pharms |
| October 1, 2004 | NDA021735 | Terconazole TERCONAZOLE | Fougera |
| April 28, 2004 | ANDA076294 | Ketoconazole KETOCONAZOLE | Fougera Pharms |
| August 18, 2003 | ANDA076453 | Lidocaine and prilocaine LIDOCAINE AND PRILOCAINE | Fougera Pharms |
| January 31, 2002 | ANDA065067 | Clindamycin CLINDAMYCIN PHOSPHATE | Fougera Pharms |
| June 5, 2001 | ANDA075502 | Clotrimazole and betamethasone dipropionate CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | Fougera Pharms |
| January 28, 2000 | ANDA064160 | Clindamycin CLINDAMYCIN PHOSPHATE | Fougera Pharms |
| June 22, 1999 | ANDA075373 | Betamethasone dipropionate BETAMETHASONE DIPROPIONATE | Fougera Pharms |
| February 8, 1999 | ANDA075391 | Clobetasol propionate CLOBETASOL PROPIONATE | Fougera Pharms |
| June 5, 1997 | ANDA064159 | Clindamycin CLINDAMYCIN PHOSPHATE | Fougera Pharms Inc |
| February 27, 1995 | ANDA072934 | Fluocinonide FLUOCINONIDE | Fougera Pharms Inc |
| May 28, 1993 | ANDA081203 | Hydrocortisone HYDROCORTISONE | Fougera Pharms Inc |
| December 30, 1988 | NDA019828 | Oxiconazole nitrate OXISTAT | Fougera |
| December 16, 1986 | ANDA089414 | Hydrocortisone HYDROCORTISONE | Fougera Pharms Inc |
| August 12, 1985 | ANDA070275 | Betamethasone dipropionate BETAMETHASONE DIPROPIONATE | Fougera Pharms Inc |
| September 4, 1984 | NDA019141 | Betamethasone dipropionate BETAMETHASONE DIPROPIONATE | Fougera |
| June 26, 1984 | NDA019137 | Betamethasone dipropionate BETAMETHASONE DIPROPIONATE | Fougera |
| August 31, 1983 | NDA018861 | Betamethasone valerate BETAMETHASONE VALERATE | Fougera |
| August 31, 1983 | NDA018865 | Betamethasone valerate BETAMETHASONE VALERATE | Fougera |
| August 31, 1983 | NDA018866 | Betamethasone valerate BETAMETHASONE VALERATE | Fougera |
| December 16, 1982 | ANDA088168 | Fluocinolone acetonide FLUOCINOLONE ACETONIDE | Fougera Pharms Inc |
| March 9, 1978 | ANDA085691 | Triamcinolone acetonide TRIAMCINOLONE ACETONIDE | Fougera Pharms |
| March 9, 1978 | ANDA085692 | Triamcinolone acetonide TRIAMCINOLONE ACETONIDE | Fougera Pharms |
| April 30, 1976 | ANDA080693 | Hydrocortisone HYDROCORTISONE | Fougera Pharms Inc |
| April 16, 1975 | ANDA080692 | Hydrocortisone HYDROCORTISONE | Fougera Pharms |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
No recall of these products (by NDC code) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026