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Drug company (FDA labeler)

Cosette Pharmaceuticals, Inc.

NDC labeler code: 0713

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.

At a glance

41Prescription medicines
88Products (NDC)
65FDA applications
5Recalls

Prescription medicines

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.
ApprovedApplicationMedicineSponsor
November 10, 2025ANDA218273 Ciprofloxacin hydrochloride and hydrocortisone
CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE		Cosette Pharms Nc
November 13, 2024ANDA217126 Sucralfate
SUCRALFATE		Cosette Pharms Nc
February 16, 2024ANDA216103 Nitroglycerin
NITROGLYCERIN		Cosette Pharms Nc
July 12, 2023ANDA216323 Metronidazole
METRONIDAZOLE		Cosette Pharms Nc
January 23, 2023ANDA216692 Metronidazole
METRONIDAZOLE		Cosette Pharms Nc
September 13, 2022ANDA214136 Tazarotene
TAZAROTENE		Cosette Pharms Nc
September 13, 2022ANDA215433 Tazarotene
TAZAROTENE		Cosette Pharms Nc
March 31, 2022ANDA210178 Dapsone
DAPSONE		Cosette Pharms Nc
November 23, 2021ANDA214864 Betaine
BETAINE		Novitium Pharma
September 28, 2021ANDA213626 Prochlorperazine
PROCHLORPERAZINE EDISYLATE		Viwit Pharm
February 11, 2021ANDA213724 Hydrocortisone valerate
HYDROCORTISONE VALERATE		Cosette Pharms Nc
May 11, 2020ANDA210765 Calcipotriene and betamethasone dipropionate (betamethasone dipropionate / calcipotriene)
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE		Cosette Pharms Nc
March 4, 2020ANDA211764 Hydrocortisone valerate
HYDROCORTISONE VALERATE		Cosette Pharms Nc
June 21, 2019NDA210557 Bremelanotide
VYLEESI (AUTOINJECTOR)		Cosette
November 5, 2018ANDA210747 Fluocinolone acetonide
FLUOCINOLONE ACETONIDE		Cosette Pharms Nc
October 12, 2018ANDA210217 Betamethasone dipropionate
BETAMETHASONE DIPROPIONATE		Cosette Pharms Nc
December 22, 2017ANDA208662 Tazarotene
TAZAROTENE		Cosette Pharms Nc
October 6, 2017ANDA209114 Nystatin
NYSTATIN		Cosette
January 12, 2017ANDA205592 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE		Cosette Pharms Nc
June 29, 2012ANDA200386 Promethazine hydrochloride and codeine phosphate
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE		Cosette Pharms Nc
June 28, 2012ANDA091687 Promethazine hydrochloride and dextromethorphan hydrobromide
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE		Cosette Pharms Nc
March 24, 2011ANDA078468 Calcipotriene
CALCIPOTRIENE		Cosette Pharms Nc
January 19, 2011ANDA078178 Metronidazole
METRONIDAZOLE		Cosette Pharms Nc
December 20, 2010ANDA078463 Ciclopirox
CICLOPIROX		Cosette Pharms Nc
October 8, 2010ANDA065438 Griseofulvin
GRISEOFULVIN		Cosette Pharms Nc
July 23, 2010NDA200175 Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
TRIBENZOR		Cosette
July 10, 2009NDA022307 Prasugrel
EFFIENT		Cosette
December 19, 2007ANDA077549 Metronidazole
METRONIDAZOLE		Cosette Pharms Nc
September 26, 2007NDA022100 Amlodipine and olmesartan medoxomil
AZOR		Cosette
April 24, 2007ANDA078162 Halobetasol propionate
HALOBETASOL PROPIONATE		Cosette Pharms Nc
March 9, 2007ANDA077553 Terconazole
TERCONAZOLE		Sun Pharma Canada
June 30, 2006ANDA077055 Fluticasone propionate
FLUTICASONE PROPIONATE		Cosette Pharms Nc
June 20, 2006ANDA077401 Mometasone furoate
MOMETASONE FUROATE		Cosette Pharms Nc
May 22, 2006ANDA077447 Mometasone furoate
MOMETASONE FUROATE		Cosette Pharms Nc
March 3, 2006ANDA077168 Fluticasone propionate
FLUTICASONE PROPIONATE		Cosette Pharms Nc
February 6, 2006ANDA040609 Hydrocortisone and acetic acid
HYDROCORTISONE AND ACETIC ACID		Cosette Pharms Nc
September 2, 2005NDA021774 Zolpidem tartrate
AMBIEN CR		Cosette
June 14, 2005ANDA077109 Halobetasol propionate
HALOBETASOL PROPIONATE		Cosette Pharms Nc
April 11, 2005ANDA076942 Ketoconazole
KETOCONAZOLE		Cosette Pharms Nc
June 5, 2003NDA021532 Olmesartan medoxomil and hydrochlorothiazide
BENICAR HCT		Cosette
April 25, 2002NDA021286 Olmesartan medoxomil
BENICAR		Cosette
February 5, 2002ANDA040428 Promethazine hydrochloride
PROMETHAZINE HYDROCHLORIDE		Cosette Pharms Nc
January 11, 2000NDA020989 Cevimeline hydrochloride
EVOXAC		Cosette
August 30, 1999ANDA075528 Clomiphene citrate
CLOMID		Cosette
June 13, 1995ANDA074204 Fluocinonide
FLUOCINONIDE EMULSIFIED BASE		Cosette Pharms Nc
April 29, 1994ANDA064054 Gentamicin sulfate
GENTAMICIN SULFATE		Cosette Pharms Nc
April 29, 1994ANDA064056 Gentamicin sulfate
GENTAMICIN SULFATE		Cosette Pharms Nc
February 16, 1994ANDA074089 Clobetasol propionate
CLOBETASOL PROPIONATE		Cosette Pharms Nc
November 24, 1993ANDA040058 Prochlorperazine
PROCHLORPERAZINE		Cosette Pharms Nc
December 16, 1992NDA019908 Zolpidem tartrate
AMBIEN		Cosette
September 28, 1992ANDA074027 Desonide
DESONIDE		Cosette Pharms Nc
February 14, 1992ANDA073085 Fluocinonide
FLUOCINONIDE		Cosette Pharms Nc
May 31, 1991ANDA089797 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE		Cosette Pharms Nc
May 31, 1991ANDA089798 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE		Cosette Pharms Nc
December 23, 1988ANDA089795 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE		Cosette Pharms Nc
December 23, 1988ANDA089796 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE		Cosette Pharms Nc
July 26, 1988ANDA089524 Fluocinolone acetonide
FLUOCINOLONE ACETONIDE		Cosette Pharms Nc
July 26, 1988ANDA089526 Fluocinolone acetonide
FLUOCINOLONE ACETONIDE		Cosette Pharms Nc
August 14, 1987ANDA087165 Promethazine hydrochloride
PROMETHEGAN		Cosette Pharms Nc
August 10, 1987ANDA071467 Betamethasone dipropionate
BETAMETHASONE DIPROPIONATE		Cosette Pharms Nc
August 14, 1986ANDA089129 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE		Cosette Pharms Nc
December 19, 1985ANDA070069 Betamethasone valerate
BETA-VAL		Cosette Pharms Nc
October 4, 1983ANDA086557 Ergotamine tartrate and caffeine
MIGERGOT		Cosette
March 24, 1983NDA018642 Betamethasone valerate
BETA-VAL		Cosette Pharms Nc
May 25, 1976ANDA061966 Nystatin
NYSTATIN		Cosette Pharms Nc

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

2022

  1. January 26, 2022 · Class II · Terminated · D-0198-2024 · Terconazole

    CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applicator, Rx only, Manufactured by: Cosette Pharmaceuticals, Inc., 111 Coolidge Street, South Plainfield, NJ 07080. NDC: 0713-0552-73

2018

  1. January 19, 2018 · Class III · Terminated · D-0250-2018 · Ciclopirox

    Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.

    Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories, Inc., South Plainfiel

2017

  1. June 2, 2017 · Class III · Terminated · D-0945-2017 · Clobetasol propionate

    Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.

    G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tube (NDC 0713-0656-31, c) 45 g tube (NDC 0713-0656-37), d) 60 g tube (NDC 0713-0656-60), Rx Only, Manufactured by G & W La

  2. March 20, 2017 · Class III · Terminated · D-0636-2017 · Ciclopirox

    Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.

    Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15), b) 30 g tubes (NDC 0713-0638-31), and c) 90 g tubes (NDC 0713-0638-18), Rx only, Manufactured by: G&W Laboratories, Inc., South Plainfeld

2013

  1. September 30, 2013 · Class III · Terminated · D-391-2014 · Fluocinolone acetonide

    Failed Content Uniformity Specifications; at the 18 month time point.

    G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

FDA Enforcement Report search → · Report an error →