Orange Book snapshot 21: Products

Products page 27 of 799 · 39,901 matching rows.

Source row, Application type, Application number table
Source row	Application type	Application number	Product number	Ingredient raw	Dosage form / route raw	Dosage form	Route	Trade name	Applicant	Strength raw	TE raw	TE JSON	Approval date	Approval date raw	Approved before 1982	RLD	RS	Product type	Applicant full name	Raw row SHA-256
1302	A	040052	003	THEOPHYLLINE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	THEOPHYLLINE	INWOOD LABS	200MG		[]	1994-02-14	Feb 14, 1994	No	No	No	DISCN	INWOOD LABORATORIES INC SUB FOREST LABORATORIES INC	`19fdaf3473fb624eea4477b25d3fbd9248161ee73458fce4f2cf57a06e4520ca`
1303	A	040052	004	THEOPHYLLINE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	THEOPHYLLINE	INWOOD LABS	300MG		[]	1994-02-14	Feb 14, 1994	No	No	No	DISCN	INWOOD LABORATORIES INC SUB FOREST LABORATORIES INC	`5c0110ffb23e26f629ab79b7c09ee85a567c6fbefb87a895ede6797e7f9f524a`
1304	A	087462	001	THEOPHYLLINE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	THEOPHYLLINE	SANDOZ	260MG		[]	1982-05-11	May 11, 1982	No	No	No	DISCN	SANDOZ INC	`554c465bb54ca8f5cbbe36de8c79e665f80926aa0e7a4118c76d6d30ba618509`
1305	A	088255	001	THEOPHYLLINE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	THEOPHYLLINE-SR	SCHERER RP	300MG		[]	1986-06-12	Jun 12, 1986	No	No	No	DISCN	RP SCHERER NORTH AMERICA DIV RP SCHERER CORP	`f483341cee3cc07378b32e165831f7e2a943680de4c75a460da1c14a2b1ea46c`
1306	A	087010	001	THEOPHYLLINE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	THEOVENT	SCHERING	125MG		[]	1985-01-31	Jan 31, 1985	No	No	No	DISCN	SCHERING CORP SUB SCHERING PLOUGH CORP	`f7d4f25d5aca1d653e183e672822a3fb2d73b08a8baf2fd0554e97e9a6c61ee4`
1307	A	087910	001	THEOPHYLLINE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	THEOVENT	SCHERING	250MG		[]	1985-01-31	Jan 31, 1985	No	No	No	DISCN	SCHERING CORP SUB SCHERING PLOUGH CORP	`22228c2646f17e4974a4df350972b7c43327ce5f73151f22bfe14428be647180`
1308	N	011120	016	CHLORPROMAZINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	THORAZINE	GLAXOSMITHKLINE	30MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	GLAXOSMITHKLINE	`a9053e7ae9b20c9b26c15cfc77d5e1b617fa387489d522a8b09ff37fe7e31a4c`
1309	N	011120	017	CHLORPROMAZINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	THORAZINE	GLAXOSMITHKLINE	75MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	GLAXOSMITHKLINE	`f1a4eef8e2d55b4f7eea82cde9891d389c22bec6f1943877e0e4f72bb6b5f996`
1310	N	011120	018	CHLORPROMAZINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	THORAZINE	GLAXOSMITHKLINE	150MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	GLAXOSMITHKLINE	`13553467b98d071b00afcdc01e59f01c29b078f1eab3afef19620bbb0ee0f1a3`
1311	N	011120	019	CHLORPROMAZINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	THORAZINE	GLAXOSMITHKLINE	200MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	GLAXOSMITHKLINE	`faa0d390a438bb081e5cd81aa4c47f00135456c8b07b46e0f90760d5cb0f6423`
1312	N	011120	020	CHLORPROMAZINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	THORAZINE	GLAXOSMITHKLINE	300MG		[]		Approved Prior to Jan 1, 1982	Yes	No	No	DISCN	GLAXOSMITHKLINE	`c387b3b8be7663b5ad17f27890f8fa6f3adae0bba894d55a4c479e6731f761f2`
1313	N	020401	001	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TIAZAC	BAUSCH	120MG	AB4	["AB4"]	1995-09-11	Sep 11, 1995	No	Yes	No	RX	BAUSCH HEALTH US LLC	`a83c8a44b2c615a134790169cbd6b71d20336e99894be38892d9ed834da46b0d`
1314	N	020401	002	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TIAZAC	BAUSCH	180MG	AB4	["AB4"]	1995-09-11	Sep 11, 1995	No	Yes	No	RX	BAUSCH HEALTH US LLC	`21b8fc5c5e336c42a583c42d78e75c0930e57cc75195f80915cd4165acd6c2fd`
1315	N	020401	003	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TIAZAC	BAUSCH	240MG	AB4	["AB4"]	1995-09-11	Sep 11, 1995	No	Yes	No	RX	BAUSCH HEALTH US LLC	`e556df898360861f3042f17e6d85603a8766cdf1c2ecaa31a524e39182d56dde`
1316	N	020401	004	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TIAZAC	BAUSCH	300MG	AB4	["AB4"]	1995-09-11	Sep 11, 1995	No	Yes	No	RX	BAUSCH HEALTH US LLC	`50df58cc2d5899490d4431b3138cb0aa213764d6783e6d790a2572d654ddb60c`
1317	N	020401	005	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TIAZAC	BAUSCH	360MG	AB4	["AB4"]	1995-09-11	Sep 11, 1995	No	Yes	No	RX	BAUSCH HEALTH US LLC	`4611d6bb3e1b278c33136920aad6da9ea8ccbaeb427e34cf36790285aacf2c62`
1318	N	020401	006	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TIAZAC	BAUSCH	420MG	AB4	["AB4"]	1998-10-16	Oct 16, 1998	No	Yes	Yes	RX	BAUSCH HEALTH US LLC	`8fe7579b8d335de3c1113297a49548e72be13370f778fc299512b2f6905e11ad`
1319	A	213397	001	TOLTERODINE TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOLTERODINE TARTRATE	AJANTA PHARMA LTD	2MG	AB	["AB"]	2020-05-19	May 19, 2020	No	No	No	RX	AJANTA PHARMA LTD	`c2e8e45dc7b2efdf97266721dcc45403d2b886f082be40151637f8f60210be2b`
1320	A	213397	002	TOLTERODINE TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOLTERODINE TARTRATE	AJANTA PHARMA LTD	4MG	AB	["AB"]	2020-05-19	May 19, 2020	No	No	No	RX	AJANTA PHARMA LTD	`5dbec35e78d21c6972e658ca151b38feae630d84e60da0db7983b65981cb9bc4`
1321	A	213858	001	TOLTERODINE TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOLTERODINE TARTRATE	AMTA	2MG	AB	["AB"]	2021-02-02	Feb 2, 2021	No	No	No	RX	AMTA LABS LTD	`a19c9779d6e56360db9191151dc9dac24dcf6bc4961259c1827fab2f60020e6a`
1322	A	213858	002	TOLTERODINE TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOLTERODINE TARTRATE	AMTA	4MG	AB	["AB"]	2021-02-02	Feb 2, 2021	No	No	No	RX	AMTA LABS LTD	`17147fbf283579b9dc27e313a7b6cf6552ede0ffd3300ddd3e654ab6a5e5f668`
1323	A	206419	001	TOLTERODINE TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOLTERODINE TARTRATE	HETERO LABS LTD III	2MG	AB	["AB"]	2017-12-12	Dec 12, 2017	No	No	No	RX	HETERO LABS LTD UNIT III	`690960c529d5ccd01ce52e878696279b61e2aed66208b820673b233f5b34c88a`
1324	A	206419	002	TOLTERODINE TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOLTERODINE TARTRATE	HETERO LABS LTD III	4MG	AB	["AB"]	2017-12-12	Dec 12, 2017	No	No	No	RX	HETERO LABS LTD UNIT III	`ced669ac4148b87400d09ddf91bcda7d2f64c70798299d530548d810eb5b0e02`
1325	A	204562	001	TOLTERODINE TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOLTERODINE TARTRATE	INVENTIA HLTHCARE	2MG	AB	["AB"]	2019-08-19	Aug 19, 2019	No	No	No	RX	INVENTIA HEALTHCARE PRIVATE LTD	`a59ea33209b297e2219bde70000006ed0e5d10ea5b085896f60118c3f69a930d`
1326	A	204562	002	TOLTERODINE TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOLTERODINE TARTRATE	INVENTIA HLTHCARE	4MG	AB	["AB"]	2019-08-19	Aug 19, 2019	No	No	No	RX	INVENTIA HEALTHCARE PRIVATE LTD	`e679a8c94177a308023dcaf8afeafcc89d5877a85b6fb071fe27f0b9b9f23741`
1327	A	201486	001	TOLTERODINE TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOLTERODINE TARTRATE	MYLAN	2MG	AB	["AB"]	2013-10-31	Oct 31, 2013	No	No	No	RX	MYLAN PHARMACEUTICALS INC	`4f0bd027e351d5b714e87707bc18fb859b7667b224a35294340d63dceea79836`
1328	A	201486	002	TOLTERODINE TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOLTERODINE TARTRATE	MYLAN	4MG	AB	["AB"]	2013-10-31	Oct 31, 2013	No	No	No	RX	MYLAN PHARMACEUTICALS INC	`83ffc13cdf58d3ea6094351f98e36dc8bd61c7fadaf93e2501ac749df60b4be3`
1329	A	079141	001	TOLTERODINE TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOLTERODINE TARTRATE	TEVA PHARMS USA	2MG	AB	["AB"]	2016-11-22	Nov 22, 2016	No	No	No	RX	TEVA PHARMACEUTICALS USA	`314794f9c328cdbe245b5d57ddeb36fc08e86125cbc694cfd545042895f87d24`
1330	A	079141	002	TOLTERODINE TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOLTERODINE TARTRATE	TEVA PHARMS USA	4MG	AB	["AB"]	2016-11-22	Nov 22, 2016	No	No	No	RX	TEVA PHARMACEUTICALS USA	`5a71c907ee2b64c98f5f9d6e407774c26f7ab6a39c49adca0f90ec0c78615bc7`
1331	A	203016	001	TOLTERODINE TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOLTERODINE TARTRATE	TORRENT	2MG	AB	["AB"]	2015-08-11	Aug 11, 2015	No	No	No	RX	TORRENT PHARMACEUTICALS LTD	`442d05ab6f1bb49681cdcc0c18ea3a6a2501bb23e4cf72bf972427f1303b927d`
1332	A	203016	002	TOLTERODINE TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOLTERODINE TARTRATE	TORRENT	4MG	AB	["AB"]	2015-08-11	Aug 11, 2015	No	No	No	RX	TORRENT PHARMACEUTICALS LTD	`5d11b09e13cc9888fdad7c92edf7e2e93d888b19defae66315b18fe29b2e09c1`
1333	A	210278	001	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOPIRAMATE	GLENMARK PHARMS LTD	25MG	AB2	["AB2"]	2021-02-01	Feb 1, 2021	No	No	No	RX	GLENMARK PHARMACEUTICALS LTD	`f97155efd2c8a7a21ad4609e099f6ccdd69a40e0b739c9a801c54aef5b657abc`
1334	A	210278	002	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOPIRAMATE	GLENMARK PHARMS LTD	50MG	AB2	["AB2"]	2021-02-01	Feb 1, 2021	No	No	No	RX	GLENMARK PHARMACEUTICALS LTD	`febf35823b021b1c0ce7ba0003283f7651052b27367010faf4305d105673b3d7`
1335	A	210278	003	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOPIRAMATE	GLENMARK PHARMS LTD	100MG	AB2	["AB2"]	2021-02-01	Feb 1, 2021	No	No	No	RX	GLENMARK PHARMACEUTICALS LTD	`8dd67c59f695b6bed74fd3a1e5e594d9d9b0774f18ce86bd0fba92fe6fa7b7b8`
1336	A	210278	004	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOPIRAMATE	GLENMARK PHARMS LTD	150MG	AB2	["AB2"]	2021-02-01	Feb 1, 2021	No	No	No	RX	GLENMARK PHARMACEUTICALS LTD	`8742f3c930f80c70d5b276af73830d7d3c8714d59ff2ab47b07416ba6148d3b3`
1337	A	210278	005	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOPIRAMATE	GLENMARK PHARMS LTD	200MG	AB2	["AB2"]	2021-02-01	Feb 1, 2021	No	No	No	RX	GLENMARK PHARMACEUTICALS LTD	`6e5e3104f04915cb628f012a01200c7a94de137c8815673c9be922d54f155aaa`
1338	A	207382	001	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOPIRAMATE	ZYDUS PHARMS	25MG	AB1	["AB1"]	2017-11-24	Nov 24, 2017	No	No	No	RX	ZYDUS PHARMACEUTICALS USA INC	`07cc6bd0252e0e3870cc1c4174c5e84fe95ca39ce4ffd03c17ac8e7577527d9d`
1339	A	207382	002	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOPIRAMATE	ZYDUS PHARMS	50MG	AB1	["AB1"]	2017-11-24	Nov 24, 2017	No	No	No	RX	ZYDUS PHARMACEUTICALS USA INC	`ef57443985faecb483c569bad183737b920745e8800280ea4f9e31d712dd8959`
1340	A	207382	003	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TOPIRAMATE	ZYDUS PHARMS	100MG	AB1	["AB1"]	2017-11-24	Nov 24, 2017	No	No	No	RX	ZYDUS PHARMACEUTICALS USA INC	`d41445b1670cf119a9e9f79291906eed4e90eaf20fee7b689db4e71753b2fc2b`
1341	A	071798	001	PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES	KV PHARM	120MG;5MG		[]	1989-03-16	Mar 16, 1989	No	No	No	DISCN	KV PHARMACEUTICAL CO	`ef27e3b0bfdd9d8493cebc26934efae25db91ef43b20b6828ea109298639345b`
1342	N	201635	001	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TROKENDI XR	SUPERNUS PHARMS	25MG	AB1	["AB1"]	2013-08-16	Aug 16, 2013	No	Yes	No	RX	SUPERNUS PHARMACEUTICALS INC	`02e942c087b3e06fc19f3a7affaff45474bc133966b4d2db30c88432c45f3336`
1343	N	201635	002	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TROKENDI XR	SUPERNUS PHARMS	50MG	AB1	["AB1"]	2013-08-16	Aug 16, 2013	No	Yes	No	RX	SUPERNUS PHARMACEUTICALS INC	`09fb016bbbc9587a805f8809bf56db0fa34a7714bf10e1a58ba3fd2b40cbba08`
1344	N	201635	003	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TROKENDI XR	SUPERNUS PHARMS	100MG	AB1	["AB1"]	2013-08-16	Aug 16, 2013	No	Yes	No	RX	SUPERNUS PHARMACEUTICALS INC	`9fc717ffd44c9de8c79deef8068d550dc79708e95b51ff907e8e144e76d04760`
1345	N	201635	004	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TROKENDI XR	SUPERNUS PHARMS	200MG	BC	["BC"]	2013-08-16	Aug 16, 2013	No	Yes	Yes	RX	SUPERNUS PHARMACEUTICALS INC	`c4f3cadf771f2560e9ae168d87470009a9fd3e0f12615f66fdf47c8e46ff51c5`
1346	A	091289	001	TROSPIUM CHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TROSPIUM CHLORIDE	ACTAVIS LABS FL INC	60MG	AB	["AB"]	2012-10-12	Oct 12, 2012	No	No	Yes	RX	ACTAVIS LABORATORIES FL INC	`400ace7782480124f942f24b61385987dd1491a5c6c584464a25968544d8d89b`
1347	A	213185	001	TROSPIUM CHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TROSPIUM CHLORIDE	GRANULES PHARMS	60MG	AB	["AB"]	2020-04-23	Apr 23, 2020	No	No	No	RX	GRANULES PHARMACEUTICALS INC	`b74b8a0d3586110b7bd4435eeaaf53f98c97469cb6dc7ed207359f0180f0e66c`
1348	A	201291	001	TROSPIUM CHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TROSPIUM CHLORIDE	PADDOCK LLC	60MG	AB	["AB"]	2013-05-24	May 24, 2013	No	No	No	RX	PADDOCK LABORATORIES LLC	`9e9489e51c83e5d939030684f11f1a2caeda0a8a11db316dd3d321c0c2c79ba7`
1349	A	091635	001	TROSPIUM CHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TROSPIUM CHLORIDE	UPSHER SMITH LABS	60MG		[]	2015-04-29	Apr 29, 2015	No	No	No	DISCN	UPSHER SMITH LABORATORIES LLC	`4e865dabb93c8923a7ae53b1dc4b3112723c5a0a863f2729a1f5145311164963`
1350	N	207621	001	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TROXYCA ER	PFIZER	1.2MG;10MG		[]	2016-08-19	Aug 19, 2016	No	No	No	DISCN	PFIZER INC	`b0d44e0da8e2ece1f6e3ae41a5986bcfc23c93485bc8f98af3903f1479f9fabb`
1351	N	207621	002	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	CAPSULE, EXTENDED RELEASE	ORAL	TROXYCA ER	PFIZER	2.4MG;20MG		[]	2016-08-19	Aug 19, 2016	No	No	No	DISCN	PFIZER INC	`694f77d142579e2639041115190c91f15dc8e2794511aa2c2d156a5d3f39b53a`