Dexamethasone Oral Solution

Brand(s): Baycadron
Category(s): prescription
SPL Type(s): Human Prescription
Master SPL: Roxane Laboratories, Inc (2015-02-27)
Oldest Current Product: 1976-09-21
License(s): ANDA

RxNORM: ORAL SOLUTION\DEXAMETHASONE
FDAOB: ORAL\CONCENTRATE\DEXAMETHASONE
ORAL\ELIXIR\DEXAMETHASONE
ORAL\SOLUTION\DEXAMETHASONE
SPL Active: ORAL\ELIXIR\DEXAMETHASONE
ORAL\SOLUTION, CONCENTRATE\DEXAMETHASONE
ORAL\SOLUTION\DEXAMETHASONE
SPL Moiety: ORAL\ELIXIR\DEXAMETHASONE
ORAL\SOLUTION, CONCENTRATE\DEXAMETHASONE
ORAL\SOLUTION\DEXAMETHASONE

product(s) by strength(s)

dexamethasone 0.1 mg/ml oral solution

generic product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	000543177		ANDA	Roxane Laboratories, Inc	2007-11-01	DEXAMETHASONE	ORAL	SOLUTION	ANDA088248	b15200fb-1826-472b-a907-e677a272513b
2	006031147		ANDA	Qualitest Pharmaceuticals	2011-05-11	DEXAMETHASONE	ORAL	ELIXIR	ANDA091188	ce01733f-33b7-483e-9bc4-cf43937e6998
3	548790003		ANDA	Sti Pharma	1976-09-21	DEXAMETHASONE	ORAL	ELIXIR	ANDA084754	320747b3-5cf1-4e0c-b670-c6a9e72a8845
4	604320466		ANDA	Morton Grove Pharmaceuticals, Inc.	1983-07-27	DEXAMETHASONE	ORAL	ELIXIR	ANDA088254	c6eb10d2-2251-482b-8a57-fea31c05bc7e
5	646790810	Baycadron	ANDA	Wockhardt Usa Llc.	1983-07-27	DEXAMETHASONE	ORAL	ELIXIR	ANDA088254	e59d3b87-af2e-4262-b89d-e95aa79f11b7
6	649800509		ANDA	Rising Pharmaceuticals, Inc.	2011-08-01	DEXAMETHASONE	ORAL	ELIXIR	ANDA090891	7cf5c17c-a80b-4547-83b2-0d53e2b933f7
7	688500001		ANDA	Sti Pharma Llc	1976-09-21	DEXAMETHASONE	ORAL	ELIXIR	ANDA084754	20d1ffa7-0a0a-4a16-a2ec-347c21693e80

relabeler product(s)(s)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	equivalent product	application	spl
1	551543275	ANDA	Cardinal Health	1983-07-27	DEXAMETHASONE	ORAL	ELIXIR	604320466	ANDA088254	dfb8cd15-e468-4082-8e68-4f1d4ad7f283

dexamethasone 1 mg/ml oral solution

generic product(s)(s)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	000543176	ANDA	Roxane Laboratories, Inc	1983-09-01	DEXAMETHASONE	ORAL	SOLUTION, CONCENTRATE	ANDA088252	b15200fb-1826-472b-a907-e677a272513b

relabeler product(s)(s)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	equivalent product	application	spl
1	681515026	ANDA	Carilion Materials Management	1983-09-01	DEXAMETHASONE	ORAL	SOLUTION, CONCENTRATE	000543176	ANDA088252	a817ab46-54ec-4e3f-886b-04ce6ac1caf9

application(s)

#	id	title	deprecated	applicant	approved	approved drug
1	ANDA084754	DEXAMETHASONE		STI PHARMA LLC		ANDA084754_001
2	ANDA088248	DEXAMETHASONE		ROXANE LABORATORIES INC	1983-09-01	ANDA088248_001
3	ANDA088252	DEXAMETHASONE INTENSOL		ROXANE LABORATORIES INC	1983-09-01	ANDA088252_001
4	ANDA088254	DEXAMETHASONE		WOCKHARDT EU OPERATIONS SWISS AG	1983-07-27	ANDA088254_001
5	ANDA088997	DEXAMETHASONE	True	ALPHARMA US PHARMACEUTICALS DIVISION	1986-10-10	ANDA088997_001
6	ANDA090891	DEXAMETHASONE		LYNE LABORATORIES INC	2011-07-12	ANDA090891_001
7	ANDA091188	DEXAMETHASONE		VINTAGE PHARMACEUTICALS INC	2011-05-11	ANDA091188_001
8	NDA012376	DECADRON	True	MERCK AND CO INC		NDA012376_002
9	NDA012674	HEXADROL	True	ORGANON USA INC		NDA012674_001

application drug(s)

#	id	category/deprecated	ingredient strength(s)	route	dose form	rld	TE	approved	application
1	ANDA084754_001	RX	DEXAMETHASONE (0.5MG/5ML)	ORAL	ELIXIR	True	AA		DEXAMETHASONE
2	ANDA088248_001	RX	DEXAMETHASONE (0.5MG/5ML)	ORAL	SOLUTION	True		1983-09-01	DEXAMETHASONE
3	ANDA088252_001	RX	DEXAMETHASONE (1MG/ML)	ORAL	CONCENTRATE	True		1983-09-01	DEXAMETHASONE INTENSOL
4	ANDA088254_001	RX	DEXAMETHASONE (0.5MG/5ML)	ORAL	ELIXIR	False	AA	1983-07-27	DEXAMETHASONE
5	ANDA088997_001	discontinued	DEXAMETHASONE (0.5MG/5ML)	ORAL	ELIXIR	False		1986-10-10	DEXAMETHASONE
6	ANDA090891_001	RX	DEXAMETHASONE (0.5MG/5ML)	ORAL	ELIXIR	False	AA	2011-07-12	DEXAMETHASONE
7	ANDA091188_001	RX	DEXAMETHASONE (0.5MG/5ML)	ORAL	ELIXIR	False	AA	2011-05-11	DEXAMETHASONE
8	NDA012376_002	discontinued	DEXAMETHASONE (0.5MG/5ML)	ORAL	ELIXIR	False			DECADRON
9	NDA012674_001	discontinued	DEXAMETHASONE (0.5MG/5ML)	ORAL	ELIXIR	False			HEXADROL

spl(s)

#	id	title	category	type	labeler	labeler act	last update	version	product(s)	in other drug docs
1	20d1ffa7-0a0a-4a16-a2ec-347c21693e80 (view SPL)	DEXAMETHASONE ELIXIR, USP0.5 mg / 5 mL	prescription	Human Prescription	Sti Pharma Llc		2012-08-14	2	688500001
2	320747b3-5cf1-4e0c-b670-c6a9e72a8845 (view SPL)	DEXAMETHASONE ELIXIR, USP0.5 mg / 5 mL	prescription	Human Prescription	Sti Pharma		2011-12-01	3	548790003
3	7cf5c17c-a80b-4547-83b2-0d53e2b933f7 (view SPL)		prescription	Human Prescription	Rising Pharmaceuticals, Inc.	manufacture	2011-08-19	5	649800509
4	a817ab46-54ec-4e3f-886b-04ce6ac1caf9 (view SPL)	DEXAMETHASONE Tablets USP, DEXAMETHASONE Oral Solution, and DEXAMETHASONE Intensol Oral Solution (Concentrate)	prescription	Human Prescription	Carilion Materials Management	REPACK	2009-08-31	2	681515026
5	b15200fb-1826-472b-a907-e677a272513b (view SPL)		prescription	Human Prescription	Roxane Laboratories, Inc	MANUFACTURE	2015-02-27	2	000543176, 000543177, 000544179, 000544180, 000544181, 000544182, 000544183, 000544184, 000544186, 000548174, 000548175, 000548176, 000548179, 000548180, 000548181, 000548183	Dexamethasone Oral Tablet
6	c6eb10d2-2251-482b-8a57-fea31c05bc7e (view SPL)	DEXAMETHASONE ELIXIR, USP (0.5 mg/5 mL)	prescription	Human Prescription	Morton Grove Pharmaceuticals, Inc.	API MANUFACTURE	2012-01-30	2	604320466
7	ce01733f-33b7-483e-9bc4-cf43937e6998 (view SPL)	DEXAMETHASONE ELIXIR, USP 0.5 mg/5 mL	prescription	Human Prescription	Qualitest Pharmaceuticals	MANUFACTURE	2015-04-07	3	006031147
8	dfb8cd15-e468-4082-8e68-4f1d4ad7f283 (view SPL)	DEXAMETHASONE ELIXIR, USP (0.5 mg/5 mL)	prescription	Human Prescription	Cardinal Health	REPACK	2013-03-19	1	551543275
9	e59d3b87-af2e-4262-b89d-e95aa79f11b7 (view SPL)	BAYCADRON ELIXIR (Dexamethasone Elixir, USP 0.5 mg/5 mL)	prescription	Human Prescription	Wockhardt Usa Llc.		2009-07-15	4	646790810

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII