FDA Orange Book · active-ingredient family
Diltiazem hydrochloride
Diltiazem hydrochloride: 11 brands, 59 generics; first approved Nov 05, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 59 ANDA applications approved.
Brands (NDA)
11
Generics (ANDA)
59
Listed patents
0
Presentations
241
Brand (NDA) products
Originator applications
- HQ SPCLT PHARMANDA 21803820252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/100ML (1MG/ML) SOLUTION INTRAVENOUS Rx — 250MG/250ML (1MG/ML) SOLUTION INTRAVENOUS Rx — - EXELA PHARMANDA 21525220212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/125ML (1MG/ML) SOLUTION INTRAVENOUS Discontinued — 250MG/250ML (1MG/ML) SOLUTION INTRAVENOUS Discontinued — - CARDIZEM LARLDBAUSCHNDA 02139220036 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG TABLET, EXTENDED RELEASE ORAL Rx AB 180MG TABLET, EXTENDED RELEASE ORAL Rx AB 240MG TABLET, EXTENDED RELEASE ORAL Rx AB 300MG TABLET, EXTENDED RELEASE ORAL Rx AB 360MG TABLET, EXTENDED RELEASE ORAL Rx AB 420MG TABLET, EXTENDED RELEASE ORAL Rx AB - TIAZACRLDBAUSCHNDA 02040119956 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB4 180MG CAPSULE, EXTENDED RELEASE ORAL Rx AB4 240MG CAPSULE, EXTENDED RELEASE ORAL Rx AB4 300MG CAPSULE, EXTENDED RELEASE ORAL Rx AB4 360MG CAPSULE, EXTENDED RELEASE ORAL Rx AB4 420MG CAPSULE, EXTENDED RELEASE ORAL Rx AB4 - CARDIZEM CDRLDBAUSCHNDA 02006219925 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 180MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 240MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 300MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 360MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 - DILACOR XRRLDALLERGANNDA 02009219923 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 180MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 240MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - CARDIZEMRLDBIOVAIL LABS INTLNDA 02002719912 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — 25MG/VIAL INJECTABLE INJECTION Discontinued — - CARDIZEM SRRLDBIOVAILNDA 01947119894 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 90MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 120MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 180MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - CARDIZEMRLDBAUSCHNDA 01860219824 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 90MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB - DILTIAZEM HYDROCHLORIDEBIOVAILNDA 02093920006 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 180MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 240MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 300MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 360MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 420MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - BIOVAILNDA 0207921997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (59)
Abbreviated applications
- DILTIAZEM HYDROCHLORIDEMACLEODS PHARMS LTDANDA 21874420265 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 180MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 240MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 300MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 360MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 - DILTIAZEM HYDROCHLORIDEALEMBICANDA 21763320254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 90MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB - DILTIAZEM HYDROCHLORIDEZYDUS LIFESCIENCESANDA 21925320254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 90MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB - DILTIAZEM HYDROCHLORIDENOVAST LABSANDA 21803220253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, EXTENDED RELEASE ORAL Rx AB1 90MG CAPSULE, EXTENDED RELEASE ORAL Rx AB1 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB1 - DILTIAZEM HYDROCHLORIDEUTOPIC PHARMSANDA 21907320253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, EXTENDED RELEASE ORAL Rx AB1 90MG CAPSULE, EXTENDED RELEASE ORAL Rx AB1 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB1 - DILTIAZEM HYDROCHLORIDEALEMBICANDA 21696820245 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 180MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 240MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 300MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 360MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 - DILTIAZEM HYDROCHLORIDEALEMBICANDA 21858720243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB2 180MG CAPSULE, EXTENDED RELEASE ORAL Rx AB2 240MG CAPSULE, EXTENDED RELEASE ORAL Rx AB2 - DILTIAZEM HYDROCHLORIDESCIEGEN PHARMSANDA 21632720236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG TABLET, EXTENDED RELEASE ORAL Rx AB 180MG TABLET, EXTENDED RELEASE ORAL Rx AB 240MG TABLET, EXTENDED RELEASE ORAL Rx AB 300MG TABLET, EXTENDED RELEASE ORAL Rx AB 360MG TABLET, EXTENDED RELEASE ORAL Rx AB 420MG TABLET, EXTENDED RELEASE ORAL Rx AB - DILTIAZEM HYDROCHLORIDEEUGIA PHARMAANDA 2165522023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — - DILTIAZEM HYDROCHLORIDEAMTAANDA 21643920236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG TABLET, EXTENDED RELEASE ORAL Rx AB 180MG TABLET, EXTENDED RELEASE ORAL Rx AB 240MG TABLET, EXTENDED RELEASE ORAL Rx AB 300MG TABLET, EXTENDED RELEASE ORAL Rx AB 360MG TABLET, EXTENDED RELEASE ORAL Rx AB 420MG TABLET, EXTENDED RELEASE ORAL Rx AB - DILTIAZEM HYDROCHLORIDETWI PHARMSANDA 21737720233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, EXTENDED RELEASE ORAL Rx AB1 90MG CAPSULE, EXTENDED RELEASE ORAL Rx AB1 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB1 - DILTIAZEM HYDROCHLORIDESCIEGEN PHARMSANDA 21652120224 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 90MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB - DILTIAZEM HYDROCHLORIDEUTOPIC PHARMSANDA 21630420223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB2 180MG CAPSULE, EXTENDED RELEASE ORAL Rx AB2 240MG CAPSULE, EXTENDED RELEASE ORAL Rx AB2 - DILTIAZEM HYDROCHLORIDEDR REDDYS LABS SAANDA 21577520223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, EXTENDED RELEASE ORAL Rx AB1 90MG CAPSULE, EXTENDED RELEASE ORAL Rx AB1 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB1 - DILTIAZEM HYDROCHLORIDEGLENMARK PHARMS LTDANDA 21231720213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, EXTENDED RELEASE ORAL Rx AB1 90MG CAPSULE, EXTENDED RELEASE ORAL Rx AB1 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB1 - DILTIAZEM HYDROCHLORIDEACCORD HLTHCAREANDA 20699720203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB2 180MG CAPSULE, EXTENDED RELEASE ORAL Rx AB2 240MG CAPSULE, EXTENDED RELEASE ORAL Rx AB2 - DILTIAZEM HYDROCHLORIDEEDENBRIDGE PHARMSANDA 21159620194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 90MG TABLET ORAL Discontinued — 120MG TABLET ORAL Discontinued — - DILTIAZEM HYDROCHLORIDENOVAST LABSANDA 20878320195 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 180MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 240MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 300MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 360MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 - DILTIAZEM HYDROCHLORIDETWI PHARMSANDA 20523120185 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 180MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 240MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 300MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 360MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 - DILTIAZEM HYDROCHLORIDEPH HEALTHANDA 2097662018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 360MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - DILTIAZEM HYDROCHLORIDEZYDUS PHARMSANDA 20664120176 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB4 180MG CAPSULE, EXTENDED RELEASE ORAL Rx AB4 240MG CAPSULE, EXTENDED RELEASE ORAL Rx AB4 300MG CAPSULE, EXTENDED RELEASE ORAL Rx AB4 360MG CAPSULE, EXTENDED RELEASE ORAL Rx AB4 420MG CAPSULE, EXTENDED RELEASE ORAL Rx AB4 - DILTIAZEM HYDROCHLORIDEZYDUS PHARMSANDA 20653420175 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 180MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 240MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 300MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 360MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 - DILTIAZEM HYDROCHLORIDESUN PHARMANDA 20302320175 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 180MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 240MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 300MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 360MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 - DILTIAZEM HYDROCHLORIDEACTAVIS ELIZABETHANDA 2024632012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 360MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 - DILTIAZEM HYDROCHLORIDECHARTWELL RXANDA 09102220126 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB4 180MG CAPSULE, EXTENDED RELEASE ORAL Rx AB4 240MG CAPSULE, EXTENDED RELEASE ORAL Rx AB4 300MG CAPSULE, EXTENDED RELEASE ORAL Rx AB4 360MG CAPSULE, EXTENDED RELEASE ORAL Rx AB4 420MG CAPSULE, EXTENDED RELEASE ORAL Rx AB4 - DILTIAZEM HYDROCHLORIDEHIKMA FARMACEUTICAANDA 2026512012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — - DILTIAZEM HYDROCHLORIDESUN PHARMANDA 09049220115 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 180MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 240MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 300MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 360MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - DILTIAZEM HYDROCHLORIDESUN PHARMANDA 09042120105 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 180MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 240MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 300MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 360MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - DILTIAZEM HYDROCHLORIDEACTAVIS LABS FL INCANDA 07768620106 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 420MG TABLET, EXTENDED RELEASE ORAL Rx AB 360MG TABLET, EXTENDED RELEASE ORAL Rx AB 300MG TABLET, EXTENDED RELEASE ORAL Rx AB 240MG TABLET, EXTENDED RELEASE ORAL Rx AB 180MG TABLET, EXTENDED RELEASE ORAL Rx AB 120MG TABLET, EXTENDED RELEASE ORAL Rx AB - DILTIAZEM HYDROCHLORIDEHIKMAANDA 0785382008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Rx AP - DILTIAZEM HYDROCHLORIDENESHER PHARMSANDA 07656320066 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 420MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 120MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 180MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 240MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 300MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 360MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - APOTEXANDA 07639520065 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 180MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 240MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 300MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 360MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - APOTEXANDA 07615120044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 180MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 240MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 300MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - ACTAVIS LABS FL INCANDA 07540120035 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 180MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 240MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 300MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 360MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - DILTIAZEM HYDROCHLORIDERSHOSPIRAANDA 0758532002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Rx — - DILTIAZEM HYDROCHLORIDEINTL MEDICATIONANDA 0757492001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — - DILTIAZEM HYDROCHLORIDEAPOTEXANDA 07494320003 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 240MG CAPSULE, EXTENDED RELEASE ORAL Rx AB2 180MG CAPSULE, EXTENDED RELEASE ORAL Rx AB2 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB2 - DILTIAZEM HYDROCHLORIDEHOSPIRAANDA 0750042000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — - DILTIAZEM HYDROCHLORIDEVALEANT PHARMS NORTHANDA 07511619994 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 180MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 240MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 300MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 - DILTIAZEM HYDROCHLORIDEPH HEALTHANDA 07498419994 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 180MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 240MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 300MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 - DILTIAZEM HYDROCHLORIDEMYLAN LABS LTDANDA 0753751999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — - DILTIAZEM HYDROCHLORIDEBIOVAILANDA 07484519993 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 90MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 120MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - DILTIAZEM HYDROCHLORIDEHOSPIRAANDA 0751061999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — - ACTAVIS LABS FL INCANDA 07475219984 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 180MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 240MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 300MG CAPSULE, EXTENDED RELEASE ORAL Rx AB3 - DILTIAZEM HYDROCHLORIDEHOSPIRAANDA 0749411998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — - DILTIAZEM HYDROCHLORIDERISINGANDA 0750861998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Rx AP - DILTIAZEM HYDROCHLORIDEPHARMOBEDIENTANDA 07512419983 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 240MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 120MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 180MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - DILTIAZEM HYDROCHLORIDEACTAVIS LABS FL INCANDA 07485219973 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 180MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 240MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - DILTIAZEM HYDROCHLORIDEDR REDDYSANDA 0748941997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — - DILTIAZEM HYDROCHLORIDEMYLANANDA 07491019973 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, EXTENDED RELEASE ORAL Rx AB1 90MG CAPSULE, EXTENDED RELEASE ORAL Rx AB1 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB1 - DILTIAZEM HYDROCHLORIDERSSAGENTANDA 0746171996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Rx AP - DILTIAZEM HYDROCHLORIDETEVAANDA 07418519954 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 90MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB - DILTIAZEM HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 07416819954 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 90MG TABLET ORAL Discontinued — 120MG TABLET ORAL Discontinued — - DILTIAZEM HYDROCHLORIDETEVAANDA 07408419942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — - DILTIAZEM HYDROCHLORIDETEVAANDA 07407919933 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 90MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 120MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - DILTIAZEM HYDROCHLORIDEAPOTHECONANDA 07405119934 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 90MG TABLET ORAL Discontinued — 120MG TABLET ORAL Discontinued — - DILTIAZEM HYDROCHLORIDECHARTWELL MOLECULESANDA 07409319924 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 90MG TABLET ORAL Discontinued — 120MG TABLET ORAL Discontinued — - DILTIAZEM HYDROCHLORIDERISINGANDA 07283819924 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG TABLET ORAL Discontinued — 90MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - DILTIAZEM HYDROCHLORIDETEVA PHARMSANDA 07406719924 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 90MG TABLET ORAL Discontinued — 120MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
44 yr 5 mo ago
Most recent approval
6 mo ago
Approvals span 1982–2026 across 70 FDA applications.
Brand (NDA) 1116%
Generic (ANDA) 5984%
Diltiazem hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
