cocaine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
local anaesthetics	723	50-36-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: cocaine cocain benzoylmethylecgonine cocaine hydrochloride cocaine HCl	An alkaloid ester extracted from the leaves of plants including coca. It is a local anesthetic and vasoconstrictor and is clinically used for that purpose, particularly in the eye, ear, nose, and throat. It also has powerful central nervous system effects similar to the amphetamines and is a drug of abuse. Cocaine, like amphetamines, acts by multiple mechanisms on brain catecholaminergic neurons; the mechanism of its reinforcing effects is thought to involve inhibition of dopamine uptake. Molecular weight: 303.36 Formula: C17H21NO4 CLOGP: 2.57 LIPINSKI: 0 HAC: 5 HDO: 0 TPSA: 55.84 ALOGS: -1.78 ROTB: 5 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

cocaine
cocain
benzoylmethylecgonine
cocaine hydrochloride
cocaine HCl

An alkaloid ester extracted from the leaves of plants including coca. It is a local anesthetic and vasoconstrictor and is clinically used for that purpose, particularly in the eye, ear, nose, and throat. It also has powerful central nervous system effects similar to the amphetamines and is a drug of abuse. Cocaine, like amphetamines, acts by multiple mechanisms on brain catecholaminergic neurons; the mechanism of its reinforcing effects is thought to involve inhibition of dopamine uptake.

Molecular weight: 303.36
Formula: C17H21NO4
CLOGP: 2.57
LIPINSKI: 0
HAC: 5
HDO: 0
TPSA: 55.84
ALOGS: -1.78
ROTB: 5

Status: ONP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	1.60 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	1 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	4.95 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	57 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	2 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	32 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.12 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	0.76 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Jan. 1, 1860	YEAR INTRODUCED

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug abuse	3036.74	91.29	764	4116	59082	50541162
Toxicity to various agents	1419.89	91.29	582	4298	211917	50388327
Completed suicide	747.90	91.29	324	4556	131565	50468679
Cardio-respiratory arrest	606.45	91.29	218	4662	53674	50546570
Respiratory arrest	483.42	91.29	159	4721	29850	50570394
Cardiac arrest	409.02	91.29	186	4694	83465	50516779
Death	273.89	91.29	235	4645	325144	50275100
Substance abuse	211.89	91.29	54	4826	4070	50596174
Drug dependence	170.30	91.29	66	4814	19693	50580551
Intentional product misuse	169.83	91.29	85	4795	46649	50553595
Poisoning deliberate	155.96	91.29	49	4831	7863	50592381
Overdose	114.84	91.29	87	4793	99640	50500604
Poisoning	105.19	91.29	41	4839	12388	50587856
Miosis	95.51	91.29	32	4848	6278	50593966
Accidental overdose	93.56	91.29	43	4837	19490	50580754

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug abuse	6445.24	57.12	1956	9036	77927	29485608
Toxicity to various agents	2240.83	57.12	1136	9856	172525	29391010
Intentional product misuse	570.47	57.12	271	10721	34390	29529145
Cardio-respiratory arrest	484.52	57.12	275	10717	50326	29513209
Drug dependence	474.75	57.12	205	10787	20776	29542759
Respiratory arrest	394.28	57.12	192	10800	25641	29537894
Substance abuse	377.87	57.12	128	10864	6659	29556876
Completed suicide	348.35	57.12	279	10713	89967	29473568
Coma	299.98	57.12	185	10807	39265	29524270
Cardiac arrest	248.68	57.12	225	10767	85366	29478169
Poisoning	230.14	57.12	99	10893	9894	29553641
Asphyxia	214.65	57.12	79	10913	5236	29558299
Overdose	212.66	57.12	200	10792	79619	29483916
Miosis	179.97	57.12	78	10914	7931	29555604
Alcohol abuse	123.49	57.12	50	10942	4283	29559252
Incorrect route of product administration	122.97	57.12	66	10926	10735	29552800
Mydriasis	122.91	57.12	55	10937	6030	29557505
Pulmonary oedema	119.16	57.12	110	10882	42625	29520910
Poisoning deliberate	113.20	57.12	51	10941	5680	29557855
Agitation	109.33	57.12	114	10878	51190	29512345
Drug use disorder	106.23	57.12	42	10950	3380	29560155
Diarrhoea	103.26	57.12	5	10987	332693	29230842
Depressed level of consciousness	100.85	57.12	94	10898	36848	29526687
Postmortem blood drug level abnormal	100.09	57.12	23	10969	272	29563263
Drug ineffective	99.67	57.12	10	10982	363160	29200375
Death	96.80	57.12	312	10680	341772	29221763
Respiratory depression	89.01	57.12	58	10934	13465	29550070
Substance use disorder	85.43	57.12	20	10972	258	29563277
Withdrawal syndrome	84.47	57.12	52	10940	10940	29552595
Toxicologic test abnormal	81.84	57.12	22	10970	511	29563024
Pneumonia	77.73	57.12	13	10979	320159	29243376
Fatigue	76.61	57.12	13	10979	316808	29246727
Intentional product use issue	75.76	57.12	86	10906	42412	29521123
Cluster headache	69.66	57.12	19	10973	467	29563068
Pyrexia	69.07	57.12	12	10980	287610	29275925
Asthenia	67.42	57.12	3	10989	215247	29348288
Bradypnoea	66.31	57.12	27	10965	2344	29561191
Aggression	60.09	57.12	70	10922	35471	29528064
Nausea	59.53	57.12	17	10975	289238	29274297
Opiates positive	59.25	57.12	17	10975	505	29563030
Anaemia	59.21	57.12	4	10988	200947	29362588
Rash	58.29	57.12	3	10989	189816	29373719

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug abuse	9346.19	59.87	2635	12445	129739	64353913
Toxicity to various agents	3361.35	59.87	1633	13447	361880	64121772
Cardio-respiratory arrest	1026.75	59.87	486	14594	97907	64385745
Completed suicide	917.18	59.87	597	14483	223817	64259835
Respiratory arrest	825.54	59.87	347	14733	52638	64431014
Intentional product misuse	734.33	59.87	351	14729	71944	64411708
Cardiac arrest	605.84	59.87	401	14679	153663	64329989
Drug dependence	592.31	59.87	240	14840	33072	64450580
Substance abuse	462.77	59.87	144	14936	9148	64474504
Death	360.63	59.87	499	14581	482206	64001446
Poisoning	339.02	59.87	143	14937	21736	64461916
Coma	307.49	59.87	213	14867	87402	64396250
Overdose	272.09	59.87	254	14826	159312	64324340
Miosis	271.79	59.87	106	14974	13160	64470492
Asphyxia	256.18	59.87	93	14987	9473	64474179
Poisoning deliberate	249.35	59.87	100	14980	13358	64470294
Incorrect route of product administration	188.05	59.87	97	14983	23201	64460451
Agitation	158.71	59.87	145	14935	88222	64395430
Alcohol abuse	155.82	59.87	54	15026	4798	64478854
Mydriasis	153.87	59.87	74	15006	15238	64468414
Drug use disorder	144.15	59.87	54	15026	6000	64477652
Depressed level of consciousness	141.11	59.87	131	14949	81305	64402347
Diarrhoea	140.56	59.87	7	15073	722697	63760955
Drug ineffective	136.50	59.87	18	15062	840229	63643423
Pulmonary oedema	131.39	59.87	124	14956	78550	64405102
Postmortem blood drug level abnormal	128.88	59.87	30	15050	617	64483035
Respiratory depression	126.86	59.87	75	15005	23368	64460284
Substance use disorder	122.67	59.87	26	15054	341	64483311
Fatigue	121.62	59.87	16	15064	748714	63734938
Accidental overdose	118.46	59.87	82	14998	33475	64450177
Suicide attempt	109.25	59.87	107	14973	70900	64412752
Nausea	101.99	59.87	29	15051	785771	63697881
Intentional overdose	101.71	59.87	115	14965	89829	64393823
Opiates positive	99.53	59.87	26	15054	872	64482780
Bradypnoea	97.82	59.87	39	15041	5120	64478532
Withdrawal syndrome	96.31	59.87	63	15017	23429	64460223
Rash	93.84	59.87	3	15077	458546	64025106
Dyspnoea	90.51	59.87	28	15052	718646	63765006
Toxicologic test abnormal	87.04	59.87	25	15055	1200	64482452
Pain	84.72	59.87	14	15066	553497	63930155
Intentional product use issue	83.35	59.87	107	14973	95257	64388395
Aggression	83.18	59.87	76	15004	46156	64437496
Asthenia	77.49	59.87	6	15074	428038	64055614
Pyrexia	77.36	59.87	18	15062	558626	63925026
Rhabdomyolysis	77.17	59.87	101	14979	91625	64392027
Amphetamines positive	74.45	59.87	16	15064	225	64483427
Altered state of consciousness	73.49	59.87	65	15015	37837	64445815
Dizziness	72.61	59.87	8	15072	430155	64053497
Pneumonia	71.82	59.87	21	15059	559555	63924097
Headache	71.46	59.87	18	15062	529449	63954203
Anaemia	69.40	59.87	5	15075	378675	64104977
Cluster headache	67.79	59.87	19	15061	834	64482818
Postmortem blood drug level	61.90	59.87	14	15066	252	64483400
Drug abuser	61.16	59.87	29	15051	5779	64477873

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Sudden infant death syndrome	17.81	15.66	3	3	53	84619

Pharmacologic Action:

Source	Code	Description
ATC	N01BC01	NERVOUS SYSTEM ANESTHETICS ANESTHETICS, LOCAL Esters of benzoic acid
ATC	R02AD03	RESPIRATORY SYSTEM THROAT PREPARATIONS THROAT PREPARATIONS Anesthetics, local
ATC	S01HA01	SENSORY ORGANS OPHTHALMOLOGICALS LOCAL ANESTHETICS Local anesthetics
ATC	S02DA02	SENSORY ORGANS OTOLOGICALS OTHER OTOLOGICALS Analgesics and anesthetics
MeSH PA	D000777	Anesthetics
MeSH PA	D000779	Anesthetics, Local
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D002492	Central Nervous System Depressants
MeSH PA	D015259	Dopamine Agents
MeSH PA	D018765	Dopamine Uptake Inhibitors
MeSH PA	D049990	Membrane Transport Modulators
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D014179	Neurotransmitter Uptake Inhibitors
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D018689	Sensory System Agents
MeSH PA	D014662	Vasoconstrictor Agents
CHEBI has role	CHEBI:35337	analeptic
CHEBI has role	CHEBI:35524	sympathomimetic
CHEBI has role	CHEBI:35640	adrenergic uptake inhibitors
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:36333	local anesthetics
CHEBI has role	CHEBI:38633	sodium channel blockers
CHEBI has role	CHEBI:50949	SSRI
CHEBI has role	CHEBI:51039	dopamine reuptake inhibitor
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:76924	plant metabolites
CHEBI has role	CHEBI:78298	environmental contaminants
CHEBI has role	CHEBI:77746	Homo sapiens metabolite

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Local anesthesia	indication	386761002
Conduction disorder of the heart	contraindication	44808001
Epilepsy	contraindication	84757009	DOID:1826
Thyrotoxicosis	contraindication	90739004	DOID:7997
Disorder of mucous membrane	contraindication	95351003
Acute disease of cardiovascular system	contraindication	128487001
Breastfeeding (mother)	contraindication	413712001
Hypertensive urgency	contraindication	443482000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.27	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
4%	GOPRELTO	GENUS LIFESCIENCES	N209963	Dec. 14, 2017	RX	SOLUTION	NASAL	10016407	Feb. 7, 2037	METHOD OF ADMINISTERING A LOCAL ANESTHETIC PRIOR TO PERFORMING A DIAGNOSTIC OR SURGICAL PROCEDURE ON A SUBJECT WITH HEPATIC OR RENAL IMPAIRMENT
4%	GOPRELTO	GENUS LIFESCIENCES	N209963	Dec. 14, 2017	RX	SOLUTION	NASAL	10149843	Feb. 7, 2037	METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA PRIOR TO PERFORMING A PROCEDURE ON, THROUGH, OR ADJACENT TO THE MUCOUS MEMBRANES
4%	GOPRELTO	GENUS LIFESCIENCES	N209963	Dec. 14, 2017	RX	SOLUTION	NASAL	10149843	Feb. 7, 2037	METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES
4%	GOPRELTO	GENUS LIFESCIENCES	N209963	Dec. 14, 2017	RX	SOLUTION	NASAL	10413505	Feb. 7, 2037	METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES
4%	GOPRELTO	GENUS LIFESCIENCES	N209963	Dec. 14, 2017	RX	SOLUTION	NASAL	10420760	Feb. 7, 2037	METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA PRIOR TO PERFORMING A PROCEDURE ON, THROUGH, OR ADJACENT TO THE MUCOUS MEMBRANES
4%	GOPRELTO	GENUS LIFESCIENCES	N209963	Dec. 14, 2017	RX	SOLUTION	NASAL	10857095	Feb. 7, 2037	METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA OF THE MUCOUS MEMBRANES
4%	GOPRELTO	GENUS LIFESCIENCES	N209963	Dec. 14, 2017	RX	SOLUTION	NASAL	10894012	Feb. 7, 2037	METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA OF THE MUCOUS MEMBRANES
4%	GOPRELTO	GENUS LIFESCIENCES	N209963	Dec. 14, 2017	RX	SOLUTION	NASAL	10933060	Feb. 7, 2037	METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA OF THE MUCOUS MEMBRANES
4%	GOPRELTO	GENUS LIFESCIENCES	N209963	Dec. 14, 2017	RX	SOLUTION	NASAL	10973811	Feb. 7, 2037	METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES IN PATIENTS WITH RENAL IMPAIRMENT
4%	GOPRELTO	GENUS LIFESCIENCES	N209963	Dec. 14, 2017	RX	SOLUTION	NASAL	10987347	Feb. 7, 2037	METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES IN PATIENTS WITH HEPATIC IMPAIRMENT
4%	GOPRELTO	GENUS LIFESCIENCES	N209963	Dec. 14, 2017	RX	SOLUTION	NASAL	9867815	Feb. 7, 2037	METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES IN GERIATRIC PATIENTS
4%	GOPRELTO	GENUS LIFESCIENCES	N209963	Dec. 14, 2017	RX	SOLUTION	NASAL	9867815	Feb. 7, 2037	METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES IN PATIENTS WITH HEPATIC IMPAIRMENT
4%	GOPRELTO	GENUS LIFESCIENCES	N209963	Dec. 14, 2017	RX	SOLUTION	NASAL	9867815	Feb. 7, 2037	METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES IN PATIENTS WITH RENAL IMPAIRMENT

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
4%	NUMBRINO	CODY LABS INC	N209575	Jan. 10, 2020	RX	SOLUTION	NASAL	Dec. 14, 2022	NEW CHEMICAL ENTITY
4%	GOPRELTO	GENUS LIFESCIENCES	N209963	Dec. 14, 2017	RX	SOLUTION	NASAL	Dec. 14, 2022	NEW CHEMICAL ENTITY
4%	NUMBRINO	CODY LABS INC	N209575	Jan. 10, 2020	RX	SOLUTION	NASAL	Jan. 10, 2023	NEW PRODUCT

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN	INHIBITOR	Ki	7.50	CHEMBL	IUPHAR
Sigma non-opioid intracellular receptor 1	Membrane receptor	Q99720	SGMR1_HUMAN		Ki	5.05	CHEMBL
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	5.14	WOMBAT-PK
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN		Ki	6.92	WOMBAT-PK
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN		Ki	5.57	WOMBAT-PK
Alpha-1A adrenergic receptor	GPCR	P35348	ADA1A_HUMAN		Ki	5.68	WOMBAT-PK
Histamine H1 receptor	GPCR	P35367	HRH1_HUMAN		Ki	5.67	WOMBAT-PK
5-hydroxytryptamine receptor 1B	GPCR	P28222	5HT1B_HUMAN		Ki	5.47	WOMBAT-PK
5-hydroxytryptamine receptor 3A	Ion channel	P46098	5HT3A_HUMAN		Ki	5.71	WOMBAT-PK
Sodium- and chloride-dependent GABA transporter 1	Transporter	P30531	SC6A1_HUMAN		IC50	5.50	WOMBAT-PK
Sodium channel protein type 11 subunit alpha	Ion channel	Q9UI33	SCNBA_HUMAN				WOMBAT-PK
Kappa-type opioid receptor	GPCR	P41145	OPRK_HUMAN		IC50	5.10	WOMBAT-PK
Cocaine- and amphetamine-regulated transcript protein	Transcription factor	Q16568	CART_HUMAN				WOMBAT-PK
Serotonin 3 receptor (5HT3)	Ion channel	O95264 P46098	5HT3B_HUMAN 5HT3A_HUMAN	ANTAGONIST	Ki	4.80	IUPHAR
Sodium channel alpha subunits; brain (Types I, II, III)	Ion channel	P35498 Q99250 Q9NY46	SCN1A_HUMAN SCN2A_HUMAN SCN3A_HUMAN		IC50	4.31	CHEMBL
Sodium channel protein type 5 subunit alpha	Ion channel	Q14524	SCN5A_HUMAN				WOMBAT-PK
Muscarinic acetylcholine receptor M1	GPCR		ACM1_RAT		Ki	4.21	CHEMBL
Sodium-dependent serotonin transporter	Transporter		SC6A4_RAT		Ki	7.35	CHEMBL
Sodium-dependent dopamine transporter	Transporter		SC6A3_RAT		Ki	7.49	CHEMBL
Transporter	Transporter		Q9WTR4_RAT		Ki	6.97	CHEMBL
Sodium-dependent dopamine transporter	Transporter		SC6A3_MOUSE		IC50	6.70	CHEMBL
Transporter	Transporter		Q63380_RAT		Ki	5.50	CHEMBL
Dopamine transporter	Transporter		SC6A3_BOVIN		IC50	7.19	CHEMBL
Dopamine transporter	Transporter		SC6A3_MACFA		IC50	7.02	CHEMBL

External reference:

ID	Source
4019690	VUID
N0000147782	NUI
D00110	KEGG_DRUG
53-21-4	SECONDARY_CAS_RN
2653	RXNORM
4017521	VANDF
4019690	VANDF
C0009170	UMLSCUI
CHEBI:27958	CHEBI
CCA	PDB_CHEM_ID
CHEMBL370805	ChEMBL_ID
CHEMBL120901	ChEMBL_ID
DB00907	DRUGBANK_ID
CHEMBL529437	ChEMBL_ID
D003042	MESH_DESCRIPTOR_UI
446220	PUBCHEM_CID
2286	IUPHAR_LIGAND_ID
I5Y540LHVR	UNII
437	MMSL
4488	MMSL
d03878	MMSL
001369	NDDF
001370	NDDF
14816004	SNOMEDCT_US
387085005	SNOMEDCT_US
74273006	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
NUMBRINO	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1961	SOLUTION	40 mg	NASAL	NDA	30 sections
cocaine hydrochloride nasal	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1971	SOLUTION	40 mg	TOPICAL	NDA authorized generic	30 sections
cocaine hydrochloride nasal	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1971	SOLUTION	40 mg	TOPICAL	NDA authorized generic	30 sections
GOPRELTO	HUMAN PRESCRIPTION DRUG LABEL	1	64950-359	SOLUTION	40 mg	NASAL	NDA	32 sections
cocaine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	64950-362	SOLUTION	40 mg	NASAL	NDA AUTHORIZED GENERIC	32 sections