Assyro AI

FDA Orange Book · active-ingredient family

Tetracycline hydrochloride

Tetracycline hydrochloride is approved as 7 brand and 46 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ACHROMYCIN V · NDA 050278

7

Brand (NDA)

46

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, fiber, extended release, for solution, injectable, ointment, suspension, suspension/drops, tablet

ProductApplicantApplicationTEApproved
ACHROMYCIN VRLD×2AVETNDA 050278ABApproved Prior to Jan 1, 1982
ACTISITESCHIFF AND CONDA 050653—Mar 25, 1994
TOPICYCLINESHIRENDA 050493—Approved Prior to Jan 1, 1982
ACHROMYCIN×2LEDERLENDA 050273—Approved Prior to Jan 1, 1982
ACHROMYCINSTORZNDA 050266—Approved Prior to Jan 1, 1982
ACHROMYCINSTORZNDA 050268—Approved Prior to Jan 1, 1982
ACHROMYCIN VLEDERLENDA 050263—Approved Prior to Jan 1, 1982

Generic (ANDA) products (46)

ProductApplicantApplicationTEApproved
TETRACYCLINE HYDROCHLORIDE×2NOVITIUM PHARMAANDA 212635ABMar 03, 2020
TETRACYCLINE HYDROCHLORIDE×2BRECKENRIDGEANDA 210662ABNov 07, 2018
TETRACYCLINE HYDROCHLORIDE×2AMNEAL PHARMS NYANDA 210674ABSep 18, 2018
TETRACYCLINE HYDROCHLORIDE×2CHARTWELL TETRAANDA 062752ABAug 12, 1988
TETRACYCLINE HYDROCHLORIDE×2PVT FORMANDA 062686—Jul 24, 1986
TETRACYCLINE HYDROCHLORIDE×2SUPERPHARMANDA 062540—Mar 21, 1985
BRISTACYCLINE×2BRISTOLANDA 061658—Approved Prior to Jan 1, 1982
BRISTACYCLINE×2BRISTOLANDA 061888—Approved Prior to Jan 1, 1982
CYCLOPAR×2WARNER CHILCOTTANDA 061725—Approved Prior to Jan 1, 1982
CYCLOPARWARNER CHILCOTTANDA 062175—Approved Prior to Jan 1, 1982
CYCLOPAR×2WARNER CHILCOTTANDA 062332—Approved Prior to Jan 1, 1982
PANMYCINPHARMACIA AND UPJOHNANDA 060347—Approved Prior to Jan 1, 1982
RETET×2SOLVAYANDA 061443—Approved Prior to Jan 1, 1982
ROBITET×2WYETH AYERSTANDA 061734—Approved Prior to Jan 1, 1982
SUMYCIN×4APOTHECONANDA 060429—Approved Prior to Jan 1, 1982
TETRACHEL×2ANGUSANDA 060343—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDE×2ABBOTTANDA 061802—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDEANI PHARMSANDA 061471—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDE×2AUROBINDO PHARMA USAANDA 060783—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDEELKINS SINNANDA 060059—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDE×2FERRANTEANDA 060173—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDE×2HEATHERANDA 061148—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDE×2HIKMAANDA 060768—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDE×3IMPAX LABSANDA 060469—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDE×2IVAX SUB TEVA PHARMSANDA 060704—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDEMAST MMANDA 062085—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDE×2PUREPAC PHARMANDA 060290—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDEROXANEANDA 061214—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDE×2SUN PHARM INDUSTRIESANDA 060736—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDE×2VALEANT PHARM INTLANDA 060471—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDE×2WARNER CHILCOTTANDA 062300—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDE×2WATSON LABSANDA 061837ABApproved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDE×2WATSON LABSANDA 062103—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDE×2WATSON LABSANDA 062343—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDE×2WYETH AYERSTANDA 061685—Approved Prior to Jan 1, 1982
TETRACYN×2PFIPHARMECSANDA 060082—Approved Prior to Jan 1, 1982
TETRACYN×2PFIZERANDA 060096—Approved Prior to Jan 1, 1982
SUMYCINPH HEALTHANDA 060400—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDEALPHARMA US PHARMSANDA 060633—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDEFERRANTEANDA 060174—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDEPROTERANDA 060446—Approved Prior to Jan 1, 1982
TETRACYCLINE HYDROCHLORIDEPUREPAC PHARMANDA 060291—Approved Prior to Jan 1, 1982
TETRACYNPFIPHARMECSANDA 060095—Approved Prior to Jan 1, 1982
TETRAMEDIVAX SUB TEVA PHARMSANDA 061468—Approved Prior to Jan 1, 1982
PANMYCIN×2PHARMACIA AND UPJOHNANDA 061705—Approved Prior to Jan 1, 1982
SUMYCIN×4STRIDES PHARMA INTLANDA 061147—Approved Prior to Jan 1, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Tetracycline hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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