← Snapshot 21

Orange Book snapshot 21: Products

Products page 67 of 799 · 39,901 matching rows.

Source row, Application type, Application number table
Source rowApplication typeApplication numberProduct numberIngredient rawDosage form / route rawDosage formRouteTrade nameApplicantStrength rawTE rawTE JSONApproval dateApproval date rawApproved before 1982RLDRSProduct typeApplicant full nameRaw row SHA-256
3302A075143001HYDROXYUREACAPSULE;ORALCAPSULEORALHYDROXYUREABARR500MGAB["AB"]1998-10-16Oct 16, 1998NoNoNoRXBARR LABORATORIES INC8404dc105978e8f5286d6021542f4e6dda58ccee0673cca96337f8948f8f0c1b
3303A075020002HYDROXYUREACAPSULE;ORALCAPSULEORALHYDROXYUREABARR LABS INC250MG[]2000-06-26Jun 26, 2000NoNoNoDISCNBARR LABORATORIES INC3e3dc1d3b05d3745412d2442fe11cf294ed9cad6e78a32904eb89b6b7529dd58
3304A075020001HYDROXYUREACAPSULE;ORALCAPSULEORALHYDROXYUREABARR LABS INC500MG[]1998-07-30Jul 30, 1998NoNoNoDISCNBARR LABORATORIES INC0189669d587ab86c678fd9d4d741b6aca885cd45f073d45235468746020fede3
3305A213438001HYDROXYUREACAPSULE;ORALCAPSULEORALHYDROXYUREALEADING PHARMA LLC500MGAB["AB"]2020-04-08Apr 8, 2020NoNoNoRXLEADING PHARMA LLCcfbb977b434e5040d084427bfc154182ad8fa80cd87c1b08e40101849c878c79
3306A075340001HYDROXYUREACAPSULE;ORALCAPSULEORALHYDROXYUREAPAR PHARM500MGAB["AB"]1999-02-24Feb 24, 1999NoNoNoRXPAR PHARMACEUTICAL INCd118a4aaf6a94ee80890449630972c5297c5031641f6a5c731ef9a92aacb9c6a
3307A074476001HYDROXYUREACAPSULE;ORALCAPSULEORALHYDROXYUREAROXANE500MG[]1995-08-18Aug 18, 1995NoNoNoDISCNROXANE LABORATORIES INC9bf10762d93614a94797cd5908a45422effe4dabdda05930c0346cf2ec550f98
3308A088496001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEBARREQ 25MG HYDROCHLORIDEAB["AB"]1984-06-15Jun 15, 1984NoNoNoRXBARR LABORATORIES INC3ce1e817660074d7f279bd615a1e8fbf0f07d0b12afddec8dc65975a21df46b0
3309A088487001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEBARREQ 50MG HYDROCHLORIDEAB["AB"]1984-06-15Jun 15, 1984NoNoNoRXBARR LABORATORIES INCb5e1e55a130d97bb821b58e0d8deb847f2be0966f333da7f7b5991b07285247e
3310A088488001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEBARREQ 100MG HYDROCHLORIDE[]1984-06-15Jun 15, 1984NoNoNoRXBARR LABORATORIES INC0e7401467f51f84f361691ed4d890f873b9d68926b2434911014ae4d698d0d29
3311A081127001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEBEXIMCO PHARMS USAEQ 25MG HYDROCHLORIDE[]1991-06-28Jun 28, 1991NoNoNoDISCNBEXIMCO PHARMACEUTICALS USA INC854b96dd1d78e8839d24db33820782cfd23e49e363a44a6f1b48210291200813
3312A088593001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEDURAMED PHARMS BARREQ 25MG HYDROCHLORIDE[]1984-02-29Feb 29, 1984NoNoNoDISCNDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC934d57dfafecf7d2c03c5351231a6c8bd0622b3588a39950dcd2b38d7d7b4267
3313A088594001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEDURAMED PHARMS BARREQ 50MG HYDROCHLORIDE[]1984-02-29Feb 29, 1984NoNoNoDISCNDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1235acb2e34bf96ae9b228c2217cd3482234ec5dc9f8f0475645718c6973cf32
3314A088595001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEDURAMED PHARMS BARREQ 100MG HYDROCHLORIDE[]1984-02-29Feb 29, 1984NoNoNoDISCNDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INCe24fc971ec8a0b0949fd71089cfd9bc8f3eb8473fac2a26ace7de430c86f298e
3315A201507001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEHERITAGE PHARMAEQ 25MG HYDROCHLORIDEAB["AB"]2013-06-03Jun 3, 2013NoNoNoRXHERITAGE PHARMA LABS INC5c6ad5bc7155203185a99ce90ee8fc6b6b8add7ce6d62bb7cb321719e61b3c7b
3316A201507002HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEHERITAGE PHARMAEQ 50MG HYDROCHLORIDEAB["AB"]2013-06-03Jun 3, 2013NoNoNoRXHERITAGE PHARMA LABS INC68bf437287f85815d5c15eecea8c8da7725730fd7ee6d5c493e8a7f8dab819d2
3317A040156001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEIMPAX LABS INCEQ 25MG HYDROCHLORIDEAB["AB"]1996-07-15Jul 15, 1996NoNoNoRXIMPAX LABORATORIES INC2607fc98148e157d28eccfec0cc8c64cce826053b8788c903832aa5f19436554
3318A040156002HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEIMPAX LABS INCEQ 50MG HYDROCHLORIDEAB["AB"]1996-07-15Jul 15, 1996NoNoNoRXIMPAX LABORATORIES INCc6a648dfa0a2093ad5b742e10b069861798faabb639371ca61786178bfe9f0ff
3319A087761001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEIVAX SUB TEVA PHARMSEQ 25MG HYDROCHLORIDE[]1982-03-05Mar 5, 1982NoNoNoDISCNIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USAb56375b035ea43a93ec2c63cb812fb2983cefa3a2221cdc829f2bd44733c168a
3320A087760001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEIVAX SUB TEVA PHARMSEQ 50MG HYDROCHLORIDE[]1982-03-05Mar 5, 1982NoNoNoDISCNIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USAdf17aa1ddb337d61d030a55899c67236878ba5c337f73861062012081de0d83e
3321A087656001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEPAR PHARMEQ 25MG HYDROCHLORIDE[]1982-06-11Jun 11, 1982NoNoNoDISCNPAR PHARMACEUTICAL INCc798f2e8d6d17cdf36b19d3acaf6d5ef41f93175ae30d689716b25dd0ec8533e
3322A089145001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEPAR PHARMEQ 25MG HYDROCHLORIDE[]1986-03-17Mar 17, 1986NoNoNoDISCNPAR PHARMACEUTICAL INC2c4efbdf99853aca1f95e31ac244dbbd4101b6708fd16f677511cf0285b28119
3323A087657001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEPAR PHARMEQ 50MG HYDROCHLORIDE[]1982-06-11Jun 11, 1982NoNoNoDISCNPAR PHARMACEUTICAL INCa6e92f5b8b5072d7b7b880e41f35362f46f3ab43b6eea5e3156eb81728dc5914
3324A089146001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEPAR PHARMEQ 50MG HYDROCHLORIDE[]1986-03-17Mar 17, 1986NoNoNoDISCNPAR PHARMACEUTICAL INCa7f96b93ff99d8f48697e452c757ba171be8f3e8165028636b7f6bd57de5c2fe
3325A087658001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEPAR PHARMEQ 100MG HYDROCHLORIDE[]1982-06-11Jun 11, 1982NoNoNoDISCNPAR PHARMACEUTICAL INC072f4c6022bd65ba282df91359ea6e18eb3c1f029fdf564d4dd1c064fec93f37
3326A087479001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATESANDOZEQ 25MG HYDROCHLORIDEAB["AB"]Approved Prior to Jan 1, 1982YesNoNoRXSANDOZ INC023bd399e242831354b656f1c88bc6e070c48bd5587f351e34a4b456f4c7ef67
3327A081128001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATESANDOZEQ 50MG HYDROCHLORIDE[]1991-06-28Jun 28, 1991NoNoNoDISCNSANDOZ INC1cc702245647211ad40be0eadf538a48b69fe1639b6f9f07c17399c1ee5f62ca
3328A086183001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATESANDOZEQ 50MG HYDROCHLORIDEAB["AB"]Approved Prior to Jan 1, 1982YesNoYesRXSANDOZ INC83af0302146a44dfa7850498fc9e5969b258f51760cc03e597ac1c09ceb3cf14
3329A081129001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATESANDOZEQ 100MG HYDROCHLORIDE[]1991-06-28Jun 28, 1991NoNoNoDISCNSANDOZ INC9e647ee092577f4847568928677c95f9d0a5a5e38d0a1676902988492526d06c
3330A089031001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATESUPERPHARMEQ 25MG HYDROCHLORIDE[]1987-01-02Jan 2, 1987NoNoNoDISCNSUPERPHARM CORPd652c360a587fecb9ad9e79d98f616e70027cf1d51e0795143add9eed759ff5e
3331A089032001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATESUPERPHARMEQ 50MG HYDROCHLORIDE[]1987-01-02Jan 2, 1987NoNoNoDISCNSUPERPHARM CORP5192d7963d3ba179eca8a22b852fc5181e172a29b7b27d5acec0ff1716e00dae
3332A089033001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATESUPERPHARMEQ 100MG HYDROCHLORIDE[]1987-01-02Jan 2, 1987NoNoNoDISCNSUPERPHARM CORP002aa9e49536e8d7f1f27c0d6e40b086ec0808a83799319e8545266225f80388
3333A088392001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEVANGARDEQ 25MG HYDROCHLORIDE[]1983-09-19Sep 19, 1983NoNoNoDISCNVANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO6945ef30e1e263f560eaecfee2391f573768d43ba6ca6b2f461935b1a5c4375b
3334A088393001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEVANGARDEQ 50MG HYDROCHLORIDE[]1983-09-19Sep 19, 1983NoNoNoDISCNVANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO19a3278c84ca5c9ada1cea2a049a22ce5451b6304e1cc3718e2c4f9bea8e6a4c
3335A081165001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEWATSON LABSEQ 25MG HYDROCHLORIDE[]1991-07-31Jul 31, 1991NoNoNoDISCNWATSON LABORATORIES INCc99e81750fee353e4d44911f422a12886d5ba034c7face5c52379c0416690532
3336A086698001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEWATSON LABSEQ 25MG HYDROCHLORIDE[]Approved Prior to Jan 1, 1982YesNoNoDISCNWATSON LABORATORIES INC2550cccc8fef64cf6a48195556885801ec8034b649c8656b386b0734b4ff8d53
3337A086840001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEWATSON LABSEQ 25MG HYDROCHLORIDE[]1982-07-01Jul 1, 1982NoNoNoDISCNWATSON LABORATORIES INC2b23ca38d2ba448d8fe251974a34de5affcbe52152a9624dc74d7bbaf7e4af77
3338A086695001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEWATSON LABSEQ 50MG HYDROCHLORIDE[]Approved Prior to Jan 1, 1982YesNoNoDISCNWATSON LABORATORIES INC81ff43e0a1bfc9b4deee50ed0ec90fa96180a632cb5cb9bd261b860a1178ebfb
3339A086705001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEWATSON LABSEQ 50MG HYDROCHLORIDE[]1982-07-01Jul 1, 1982NoNoNoDISCNWATSON LABORATORIES INC5806cdc8dc13ca52c7b7fc39154f2fdf2e6f48ea9b2e57de5b0124ee147548b8
3340A087767001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEWATSON LABSEQ 50MG HYDROCHLORIDE[]1982-08-16Aug 16, 1982NoNoNoDISCNWATSON LABORATORIES INC08faa4ea98484a41b0034fb58c77ac2217d000989c26bdc7cc497dc395089685
3341A086697001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEWATSON LABSEQ 100MG HYDROCHLORIDE[]Approved Prior to Jan 1, 1982YesNoNoDISCNWATSON LABORATORIES INC120b67fc89d991e11f83f4cbdfdfda0aa47dced23d11ae39ce49427b9b649917
3342A086728001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEWATSON LABSEQ 100MG HYDROCHLORIDE[]1982-10-05Oct 5, 1982NoNoNoDISCNWATSON LABORATORIES INCc1d594ab456796178bb3b76cd710037a1c81c43cc7797efd212979d18686fae5
3343A087790001HYDROXYZINE PAMOATECAPSULE;ORALCAPSULEORALHYDROXYZINE PAMOATEWATSON LABSEQ 100MG HYDROCHLORIDE[]1982-08-16Aug 16, 1982NoNoNoDISCNWATSON LABORATORIES INC3cb9478c22f4dc62d6fa88468679220290d58a0c89a06e6f5bf8c1152e837713
3344N020347001TERAZOSIN HYDROCHLORIDECAPSULE;ORALCAPSULEORALHYTRINABBOTTEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1994-12-14Dec 14, 1994NoYesNoDISCNABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV6fba03bb7dc9b19b15f2ad352b1a3c89a153fbc6b2deffb1dffcb0d37a88facb
3345N020347002TERAZOSIN HYDROCHLORIDECAPSULE;ORALCAPSULEORALHYTRINABBOTTEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1994-12-14Dec 14, 1994NoYesNoDISCNABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVa9ea32538b265abad34a0c9ecfd1eb3f253b882b6bd1854c58c570bc1d93a24c
3346N020347003TERAZOSIN HYDROCHLORIDECAPSULE;ORALCAPSULEORALHYTRINABBOTTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1994-12-14Dec 14, 1994NoYesNoDISCNABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV9a88ab53d21714d533933c9006cd550ba9aa4e578179d0332654a987a997aa38
3347N020347004TERAZOSIN HYDROCHLORIDECAPSULE;ORALCAPSULEORALHYTRINABBOTTEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1994-12-14Dec 14, 1994NoYesNoDISCNABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV437d23af0b8c1234bf5fa0636322f395d0908544a44fa51e2b8560c47bb53235
3348N207103001PALBOCICLIBCAPSULE;ORALCAPSULEORALIBRANCEPFIZER75MG[]2015-02-03Feb 3, 2015NoYesNoRXPFIZER INC7f1fea385a08c3ccd1668bfbbef57dd68792ffdf8a92baae191f080ff40bb59b
3349N207103002PALBOCICLIBCAPSULE;ORALCAPSULEORALIBRANCEPFIZER100MG[]2015-02-03Feb 3, 2015NoYesNoRXPFIZER INC2e5307e61bc933b446a3bbec803d5ad24e70f9b2eeec04001b4d4288ec6628fa
3350N207103003PALBOCICLIBCAPSULE;ORALCAPSULEORALIBRANCEPFIZER125MG[]2015-02-03Feb 3, 2015NoYesYesRXPFIZER INCd1847566b0e0e55ab90db69bed30519a0513a9779efc38e70e7c43d7c46a7142
3351A211344001IBRUTINIBCAPSULE;ORALCAPSULEORALIBRUTINIBZYDUS70MGAB["AB"]2021-03-31Mar 31, 2021NoNoNoRXZYDUS WORLDWIDE DMCCd3f37a44b74f1c1a360090f2114d1a9bd40b9e4b2575a22faaf1cb81e05ba985